TriNaV for Uterine Fibroids (PEDD-UFE Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18 - 65
Sex: Female
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Massachusetts General Hospital
No Placebo Group
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?The goal of this study is to assess of Pressure-Enabled Drug Delivery on fibroid treatment in patients undergoing UFE.
Is the drug TriNaV a promising treatment for uterine fibroids?The drug TriNaV, also known as relugolix/estradiol/norethisterone acetate, is a promising treatment for uterine fibroids. It effectively reduces heavy menstrual bleeding and improves other symptoms related to uterine fibroids. It is convenient to take as a once-daily pill and is generally well tolerated.1451314
What safety data exists for TriNaV treatment for uterine fibroids?The provided research does not contain any safety data related to TriNaV or its alternative names for the treatment of uterine fibroids. The studies focus on anesthesia and antiemetic interventions for postoperative nausea and vomiting in gynecological surgeries, but do not mention TriNaV or its safety profile.23678
What data supports the idea that TriNaV for Uterine Fibroids (also known as: TriNaV) is an effective treatment?The available research shows that TriNaV, used in transcervical fibroid ablation (TFA), is effective for treating uterine fibroids. In the SONATA trial, women experienced a significant reduction in fibroid symptoms over three years, with only 9.2% needing further surgery for heavy menstrual bleeding. Their quality of life improved, and 94% were satisfied with the treatment. Compared to other treatments like radiofrequency ablation (RFA), which also shows symptom improvement and reduced fibroid size, TriNaV offers similar benefits with low complication rates.910111215
Do I have to stop taking my current medications for the trial?The protocol does not specify if you need to stop taking your current medications. However, if you are on GnRH agonist therapy, you must have stopped it at least 6 months before the study, and if on GnRH antagonist therapy, at least 1 month before.
Eligibility Criteria
This trial is for women over 18 with uterine fibroids who have decided to undergo Uterine Fibroid Embolization (UFE). They should have symptoms like heavy bleeding or a feeling of fullness and must not be pregnant, post-menopausal, or have had certain hormone treatments recently. Women with gynecologic cancer, pelvic inflammatory disease, or allergies to specific pain medications cannot participate.Inclusion Criteria
I am a woman over 18 years old.
I experience heavy menstrual bleeding or symptoms due to large growths.
Exclusion Criteria
I have been diagnosed with endometriosis.
I have been diagnosed with a cancer that started in my reproductive organs.
I have had a procedure to treat fibroids in my uterus.
I have had my ovaries surgically removed.
I have been diagnosed with pelvic inflammatory disease.
I have not had a menstrual period for over 12 months.
I have been diagnosed with adenomyosis.
Participant Groups
The study tests the effectiveness of TriNaV in improving drug delivery during UFE procedures aimed at treating fibroids. It evaluates if this method can better reduce pain and enhance blood flow to the ovaries after treatment compared to standard approaches.
1Treatment groups
Experimental Treatment
Group I: Intervention ArmExperimental Treatment1 Intervention
Patient will undergo UFE using PEDD
TriNaV is already approved in United States for the following indications:
🇺🇸 Approved in United States as TriNav Infusion System for:
- Angiographic procedures
- Delivery of radiopaque media and therapeutic agents to selected sites in the peripheral vascular system
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Massachusetts General HospitalBoston, MA
Brigham and Women's HospitalBoston, MA
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Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
TriSalus Life Sciences, Inc.Industry Sponsor
References
Transcervical hysteroscopic resection of submucous fibroids for abnormal uterine bleeding: results regarding the degree of intramural extension. [2022]To examine the results of transcervical resection of submucous fibroids in relation to the degree of intramural extension.
[A comparison of the incidence of postoperative nausea and vomiting after propofol-fentanyl anesthesia and that after nitrous oxide-isoflurane anesthesia]. [2013]We compared the incidence of postoperative nausea and vomiting after total intravenous propofol-fentanyl anesthesia (TIVA group) and that after thiamylal-nitrous oxide-isoflurane anesthesia (GOI group) in 60 ASA physical I and II patients for elective abdominal simple total hysterectomy. When the patients returned to the ward, the incidence of nausea was lower in TIVA group than in GOI group (P
[TIVA with propofol-remifentanil or balanced anesthesia with sevoflurane-fentanyl in laparoscopic operations. Hemodynamics, awakening and adverse effects]. [2018]This study was designed to investigate the differences between TIVA with propofol/remifentanil (P/R) and balanced anaesthesia with sevoflurane/fentanyl (S/F) in gynaecological laparoscopic surgery. Emphasis was put on haemodynamic reaction, recovery profile, postoperative side effects and patient satisfaction.
Levonorgestrel-releasing intrauterine system vs. transcervical endometrial resection for dysfunctional uterine bleeding. [2016]To compare the acceptability, efficacy, adverse effects, and user satisfaction of a levonorgestrel intrauterine system (LNG-IUS) and transcervical resection of the endometrium (TCRE) for the treatment of dysfunctional uterine bleeding.
An evidence-based approach to hormonal therapies for premenopausal women with fibroids. [2015]Ovarian steroids, particularly oestrogen, are important factors for fibroid growth. This has provided a rationale for the investigation of hormonal therapies for women with fibroids. This chapter will assess the role of hormonal therapies for pre-menopausal women with fibroids. A comprehensive search of MEDLINE and EMBASE was undertaken in December 2006. Twenty-nine relevant randomized controlled trials and two systematic reviews were found. The included studies assessed gonadotrophin-releasing hormone analogues (GnRHa) alone, GnRHa plus add-back (with either progestagen, tibolone, combined oestrogen and progestagen, or raloxifene) and GnRHa given for at least 3 months prior to surgery for fibroids. Two trials assessed the effects of raloxifene alone. One trial assessed the effects of low-dose mifepristone, and a pilot study assessed the role of the selective progesterone receptor modulator, asoprisinil. GnRHa reduce fibroid and uterine volume and heavy bleeding but are associated with menopausal symptoms and bone loss, which limit long-term use. There is some evidence that add-back therapy, either progestagen, tibolone, combined oestrogen and progestagen, or raloxifene, can reduce the menopausal symptoms associated with GnRHa and/or loss of bone density, but there is insufficient good-quality research to make definitive conclusions. GnRHa given for at least 3 months before fibroid surgery improve pre-operative haemoglobin concentration and haematocrit, reduce uterine and pelvic symptoms, and reduce the rate of vertical incisions during laparotomy. Women undergoing hysterectomy are more likely to have a vaginal than an abdominal procedure. Limited evidence suggests that raloxifene may be useful in older premenopausal women with lower concentrations of background oestradiol. Limited short-term evidence of two progestogenic therapies indicates that low-dose mifepristone may improve quality of life and bleeding in the short term, and asoprisinil may improve bleeding and fibroid-related symptoms. In conclusion, more research is required on the role of hormonal therapies for women with fibroids, particularly add-back options and selective oestrogen and progesterone receptor modulators. No definitive conclusions can be reached on the basis of the limited evidence found.
A randomized controlled trial of two different interventions for the prevention of postoperative nausea and vomiting: total intravenous anaesthesia using propofol and remifentanil versus prophylactic palonosetron with inhalational anaesthesia using sevoflurane-nitrous oxide. [2018]Total intravenous anaesthesia (TIVA) can reduce the risk of postoperative nausea and vomiting (PONV) almost as much as a single antiemetic. This study compared TIVA (using propofol and remifentanil) with prophylactic palonosetron (a 5-hydroxytryptamine type 3 receptor antagonist) combined with inhalation anaesthesia using sevoflurane in 50% nitrous oxide, for the prevention of PONV. Patients were randomly assigned to one of two prophylactic interventions: (i) palonosetron 0.075 mg, intravenously before induction of inhalation anaesthesia (palonosetron group); and (ii) TIVA (propofol target blood concentration 2.5-6.0 μg/ml; remifentanil target blood concentration 2.5-6.0 ng/ml; TIVA group). Nausea/vomiting occurrence and severity were monitored immediately after the end of surgery for 24 h. The incidence of PONV was around 50% in both groups and the severity of nausea was similar in both groups. Prophylactic palonosetron with inhalational anaesthesia using sevoflurane in 50% nitrous oxide reduced the incidence of PONV after gynaecological laparoscopic surgery almost as much as TIVA using propofol and remifentanil.
Dexmedetomidine for antiemesis in gynecologic surgery: a meta-analysis of randomized controlled trials. [2022]Postoperative nausea and vomiting (PONV) is a common complication after gynecological surgeries. This meta-analysis was conducted to evaluate the efficacy of dexmedetomidine on PONV after gynecological surgeries.
A randomized, double-blind trial evaluating the efficacy of palonosetron with total intravenous anesthesia using propofol and remifentanil for the prevention of postoperative nausea and vomiting after gynecologic surgery. [2018]Palonosetron has potent and long-acting antiemetic effects for postoperative nausea and vomiting (PONV). The aim of this study was to prospectively evaluate the efficacy of palonosetron when used with total intravenous anesthesia (TIVA) using propofol and remifentanil for the prevention of PONV in patients undergoing laparoscopic gynecologic surgery.
Clinical Performance of Radiofrequency Ablation for Treatment of Uterine Fibroids: Systematic Review and Meta-Analysis of Prospective Studies. [2020]Background: Radiofrequency ablation (RFA) has emerged as a safe and effective treatment option for women with symptomatic uterine fibroids and can be delivered by laparoscopic, transvaginal, or transcervical approaches. The evidence regarding typical patient outcomes with RFA has not previously been examined in a comprehensive fashion. Materials and Methods: We performed a systematic review of prospective studies for treatment of uterine fibroids with RFA. Main outcomes were procedure time, patient recovery metrics, change in fibroid volume, symptom severity score (SSS), health-related quality of life (HRQL), and reinterventions. Data were analyzed with random effects meta-analysis and metaregression. Results: We identified 32 articles of 1283 unique patients (median age: 42 years) treated with laparoscopic RFA (19 articles), transvaginal RFA (8 articles), or transcervical fibroid ablation (5 articles). Mean procedure time was 49 minutes, time to discharge was 8.2 hours, time to normal activities was 5.2 days, and time to return to work was 5.1 days. At 12 months follow-up, fibroid volume decreased by 66%, HRQL increased by 39 points, and SSS decreased by 42 points (all P < .001 versus baseline). The annual cumulative rate of reinterventions due to fibroid-related symptoms was 4.2%, 8.2%, and 11.5% through 3 years. Conclusions: RFA of uterine fibroids significantly reduces fibroid volume, provides significant durable improvements in fibroid-related quality of life, and is associated with favorable reintervention rates.
Three-Year Results of the SONATA Pivotal Trial of Transcervical Fibroid Ablation for Symptomatic Uterine Myomata. [2020]Objective: This article reports on 3-year clinical outcomes of the Sonography Guided Transcervical Ablation of Uterine Fibroids (SONATA) pivotal trial of transcervical fibroid ablation (TFA) in women with symptomatic uterine myomata. Materials and Methods: The SONATA, prospective, controlled, multicenter interventional trial enrolled 147 premenopausal women with symptomatic uterine fibroids who underwent uterus-preserving, sonography-guided TFA with the Sonata® System (Gynesonics, Inc., Redwood City, CA, USA). Clinical outcomes were assessed over 3 years and included surgical reinterventions, Symptom Severity Score (SSS), and Health-Related Quality of Life (HRQoL) subscales of the Uterine Fibroid Symptom and Quality-of-Life Questionnaire, EuroQol 5-Dimension (EQ-5D) questionnaire, Overall Treatment Effect, treatment satisfaction, physical activity, work impairment, pregnancy outcomes, and adverse events. Results: The 3-year rates of surgical reintervention for heavy menstrual bleeding calculated by the binomial and Kaplan-Meier methods were 9.2% and 8.2%, respectively. Compared to baseline, mean SSS decreased from 55 ± 19 to 22 ± 21, HRQoL increased from 40 ± 21 to 83 ± 23, and EQ-5D increased from 0.72 ± 0.21 to 0.88 ± 0.16 (all p < 0.001). Treatment benefit on the SSS, HRQoL, and EQ-5Q exceeded the minimal clinically important difference at every follow-up visit over 3 years. At 3 years, 94% of the subjects reported treatment satisfaction, 88% reported reduced fibroid symptoms, work absenteeism due to fibroid symptoms decreased from 2.9% to 1.4%, and impairment due to fibroids decreased from 51% to 12% for work, and 58% to 14% for physical activity (all p < 0.001). No late complications occurred. Conclusions: Women treated with sonography-guided TFA in the SONATA pivotal trial experienced significant and durable reduction of fibroid-related symptoms, with low surgical reintervention rates over 3 years of follow-up.
Transcervical fibroid ablation with the Sonata™ system for treatment of submucous and large uterine fibroids. [2021]To examine the role and benefits of transcervical fibroid ablation (TFA) in the treatment of submucous and large uterine fibroids.
Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry (SAGE): Study Protocol and Preliminary Results. [2022]Transcervical fibroid ablation (TFA) is a minimally invasive, effective treatment of symptomatic uterine fibroids that utilizes intrauterine ultrasound for imaging and radiofrequency energy for ablation. Outcomes reported with TFA have been positive, with significant reductions in fibroid volume, improvements in symptom severity and health-related quality of life, and low complication and surgical reintervention rates. The SAGE registry characterizes the long-term (5-year) outcomes of TFA when used to treat symptomatic uterine fibroids in real-world usage.
The effect of transcervical resection of submucous fibroids on menstrual blood loss: A prospective cohort study. [2022]Transcervical resection of myoma (TCRM) is a widely implemented treatment for submucous fibroids. The aim of this study is to evaluate the effect of TCRM on menstrual bleeding, fibroid related symptoms and quality of life and hemoglobin (Hb) levels.
Relugolix/Estradiol/Norethisterone (Norethindrone) Acetate: A Review in Symptomatic Uterine Fibroids. [2022]An oral fixed-dose combination of relugolix/estradiol/norethisterone (also known as norethindrone) acetate (Ryeqo®; Myfembree®) has been approved for the management of heavy menstrual bleeding associated with uterine fibroids in the USA and management of moderate to severe symptoms of uterine fibroids in the EU. Relugolix is a gonadotropin releasing hormone (GnRH) receptor antagonist that decreases serum estradiol and progesterone concentrations to postmenopausal levels. The addition of estradiol/norethisterone acetate to relugolix ameliorates relugolix-induced bone loss and hot flush. In the two phase 3 LIBERTY trials, relugolix + estradiol/norethisterone substantially decreased menstrual bleeding and improved a range of other uterine fibroid symptoms in women with uterine fibroids-associated heavy menstrual bleeding. The combination was generally well tolerated, with vasomotor symptoms being the most common adverse reaction. Treatment with this combination for over up to 2 years did not induce a clinically meaningful bone loss in the majority of women. Relugolix/estradiol/norethisterone acetate, with its convenient once-daily administration, is a useful addition to current pharmacological treatment options for premenopausal women with symptomatic uterine fibroids.
Long-term health-related quality of life and symptom severity following hysterectomy, myomectomy, or uterine artery embolization for the treatment of symptomatic uterine fibroids. [2023]Few studies have directly compared different surgical procedures for uterine fibroids with respect to long-term health-related quality of life outcomes and symptom improvement.