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Radiofrequency Ablation for Adenomyosis

N/A

Recruiting

Led By Kimberly Kho, MD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least one area of focal or diffuse adenomyosis or adenomyomas that is/are contralateral to any fibroids as determined by MRI

Uterus < 16 weeks gestational size if undergoing a laparoscopic or robotic procedure (no size limit for patients planning to undergo a transabdominal hysterectomy)

Must not have

Have active pelvic inflammatory disease

Are not English speaking

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day of intervention within 4 hours of rf (radiofrequency) treatment and 2 hours of completion of hysterectomy

Awards & highlights

No Placebo-Only Group

Summary

This trial will look at the effects of a common treatment for adenomyosis (radiofrequency ablation) by studying tissue that has been removed during a planned hysterectomy.

Who is the study for?

This trial is for individuals planning a hysterectomy due to benign conditions, with confirmed adenomyosis or adenomyomas by MRI. They must be suitable for surgery, able to consent, and speak English. Excluded are those with fibroids near the target area, pregnant or lactating women, under 18s, those with certain uterine devices or requiring emergency/vaginal hysterectomy.

What is being tested?

The study tests radiofrequency ablation (RF Treatment) on adenomyosis tissue that will be removed during an already planned hysterectomy. The goal is to analyze the treated tissue pathologically to understand the effects of RF treatment on this condition.

What are the potential side effects?

While specific side effects aren't listed here as it's an observational study post-treatment analysis, typical risks may include discomfort at the treatment site, bleeding, infection risk from surgical procedures involved in both RF treatment and hysterectomy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have adenomyosis or adenomyomas diagnosed by MRI, not on the same side as any fibroids.

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My uterus is smaller than 16 weeks size for a laparoscopic surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I currently have an infection in my reproductive organs.

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I do not speak English.

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I have fibroids near my adenomyosis.

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I am unable to understand and give consent for treatment.

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I had cancer related to my reproductive organs in the last 3 years.

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I need an urgent hysterectomy.

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I am under 18 years old.

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I cannot or do not want to have a hysterectomy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day of intervention within 4 hours of rf (radiofrequency) treatment and 2 hours of completion of hysterectomy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day of intervention within 4 hours of rf (radiofrequency) treatment and 2 hours of completion of hysterectomy

This trial's timeline: 3 weeks for screening, Varies for treatment, and day of intervention within 4 hours of rf (radiofrequency) treatment and 2 hours of completion of hysterectomy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Post-operative evidence of adenomyoma tissue ablation as assessed by pathological analysis

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: RF TreatmentExperimental Treatment1 Intervention

At the time of the subject's trans-abdominal or laparoscopic hysterectomy, the ProVu System will be used to apply RF treatment to one or two adenomas, focal areas of adenomyosis, or diffuse adenomyosis.

0 / 10Eligibility criteria met