Ablative Techniques for Endometriosis
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: TriHealth Inc.
Disqualifiers: Pregnancy
No Placebo Group
Trial Summary
What is the purpose of this trial?To our knowledge, no other human studies directly compare the effectiveness of the various ablative technologies. We set out to design a study to directly compare ablative energy sources and evaluate their ability to destroy native endometriosis tissue in humans.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Ablative Techniques for Endometriosis?
Research shows that using the Argon Beam Coagulator for endometriosis treatment improved pain in 72.5% of women and helped 28% of women with infertility to conceive. Additionally, the argon laser completely removed endometriosis in an animal study, suggesting its potential effectiveness.
12345How is the treatment using Argon Beam Coagulator, CO2 Laser, and Diathermy for endometriosis different from other treatments?
This treatment is unique because it uses advanced laser and coagulation techniques to precisely target and remove endometrial tissue with minimal damage to surrounding areas, reducing blood loss and improving visualization during surgery. It offers a less invasive option compared to major surgery and can be performed during diagnostic laparoscopy, potentially speeding up treatment and improving outcomes for pain and infertility.
12346Eligibility Criteria
This trial is for adult women aged 18 or older who are scheduled for robotic assisted or laparoscopic surgery to remove endometriosis lesions due to pelvic pain symptoms. It's not open to pregnant women at the time of enrollment or surgery.Inclusion Criteria
I am a woman over 18 planning surgery for pelvic pain or endometriosis.
Exclusion Criteria
Known pregnancy at enrollment or at the time of the excision surgery
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo ablative procedures using different energy sources to treat endometriosis
0 days
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of pelvic pain
3 months
Participant Groups
The study compares three different techniques used in surgery to destroy endometriosis tissue: Diathermy, CO2 Laser, and Argon Beam Coagulator. The goal is to find out which method is most effective.
3Treatment groups
Active Control
Group I: DiathermyActive Control1 Intervention
Group II: CO2 LaserActive Control1 Intervention
Group III: Argon Beam CoagulatorActive Control1 Intervention
Argon Beam Coagulator is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Argon Plasma Coagulation for:
- Gastrointestinal bleeding
- Endoscopic hemostasis
- Lesion coagulation
🇺🇸 Approved in United States as Argon Beam Coagulator for:
- Surgical hemostasis
- Solid organ injury
- Endometriosis treatment
🇨🇦 Approved in Canada as Argon Plasma Coagulation for:
- Gastrointestinal bleeding
- Endoscopic hemostasis
🇯🇵 Approved in Japan as Argon Beam Coagulator for:
- Surgical hemostasis
- Solid organ injury
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Good Samaritan HospitalCincinnati, OH
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Who Is Running the Clinical Trial?
TriHealth Inc.Lead Sponsor
References
Laparoscopic Use of Argon Beam Coagulator in the Management of Endometriosis [2019]Fifty-five patients with endometriosis in whom argon beam coagulation was used through the laparoscope for coagulation of endometrial lesions, lysis of pelvic adhesions, uterosacral nerve ablation (LUNA) and presacral neurectomy (PSN) were evaluated retrospectively. Thirty patients (54%) had pelvic pain, and 25 patients (46%) presented with pelvic pain and/or infertility. Postoperatively, 29 (72.5%) women showed improvement of pain, 6 (15%) had no change of pain, and in 5 (12.5%) the pain became worse. Seven patients were able to conceive after longstanding infertility, for an early crude pregnancy rate of 28%. Laparoscopic use of argon beam coagulator in the treatment of endometriosis for both pain management and infertility is as effective as other electrosurgical or laser techniques.
The use of the argon laser in the treatment of experimental endometriosis. [2019]The argon laser offers several theoretical advantages over excision, electrocautery, or CO2 laser therapy for the treatment of peritoneal implants of endometriosis. Therefore, a study of the feasibility of the argon laser for the treatment of endometriosis was performed using five virgin New Zealand White rabbits. Following 6 days of estrogen administration, each animal underwent laparotomy with excision of the right uterine horn. Sections of endometrium were sutured to several peritoneal surfaces. Approximately 3 weeks later the endometrial implants were photocoagulated with the argon laser (488 nm, 2 W, 2-mm spot size, 3 to 5 seconds). Histologic examination of the sites of laser therapy demonstrated complete ablation of the endometriosis with 0.25-mm damage to the underlying tissue and surrounding tissue.
The present and future application of lasers to the treatment of endometriosis and infertility. [2013]Conventional approaches to the treatment of endometriosis usually require major surgery, prolonged use of medications or both. The laser has provided an opportunity to treat mild and moderate endometriosis at the time of diagnosis at laparoscopy, thus avoiding delays in attempts to conceive. This review describes the current use of the CO2, argon and Nd:YAG lasers in the treatment of endometriosis. Potential and future uses of the free-electron laser (FEL) are also described.
Argon Beam Coagulator in Laparoscopic Gynecologic Surgery [2019]Forty-one women underwent laparoscopic argon-enhanced electrosurgery, 17 for ovarian endometriomas and peritoneal endometriosis, 5 for dermoids, 11 for deep endometriosis of uterosacral ligaments, and 8 for tubal infertility. Argon-enhanced coagulation was used to treat the bed of peeled endometrioma walls and superficial endometriotic lesions, for hemostasis after adhesions dissection and excision of endometriosis from uterosacral ligaments, and for tubal ampulla eversion. The settings used were 4.0 SPLM with 30 to 50 W coagulation current. Argon-enhanced coagulation provided both quick and safe hemostasis, and caused minimal damage to adjacent tissues without smoke and carbonizing of tissues. Better visualization due to the absence of smoke and minimal tissue trauma will probably help reduce blood loss and operating time, and enhance long-term outcomes of surgery.
Argon plasma coagulation (APC) in gastroenterology: experimental and clinical experiences. [2019]Diathermy procedures are indispensable in interventional endoscopy. Argon beam coagulation is an innovative no-touch electrocoagulation technique in which high-frequency alternating current is delivered to the tissue through ionized argon gas.
Management of pelvic endometriosis by means of intraabdominal carbon dioxide laser. [2017]A significant number of patients with severe pelvic endometriosis are at risk of developing pelvic adhesions and/or loss of ovarian function. Although numerous surgical techniques have been advocated, none has any clear advantage over the others. This article presents a new surgical method for conservative management of pelvic endometriosis. The CO2 laser, directed via the microscope or the freehand piece of the articulated arm, was utilized to vaporize focal endometrial implants, to excise endometrial cysts, and to lyse pelvic adhesions in 54 patients. Fourteen of 23 patients (60.8%) attempting pregnancy have conceived at the time of this report. The observed advantages of laser surgery for endometriosis are a bloodless field, precision destruction (vaporization), precision cutting, and the ability to treat poorly accessible areas.