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Radiofrequency Ablation for Adenomyosis

Q: How many participants are being admitted to the research project?

<p>Affirmative, per the information on clinicaltrials.gov this experiment is actively recruiting participants. Initially posted on July 14th 2022 and last edited a day later, it seeks to enroll 20 patients at one medical centre.</p>

Q: Are there open slots for participants in this clinical investigation?

<p>Affirmative. Clinicaltrials.gov provides evidence that this specialist study, which was made available on July 14th 2022, is currently recruiting participants. It requires the recruitment of exactly 20 individuals from a single healthcare centre.</p>

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)

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

Study 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.Check my eligibility

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.See study design

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

Select...

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

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hologic, Inc.Industry Sponsor

46 Previous Clinical Trials

60,087 Total Patients Enrolled

University of Texas Southwestern Medical CenterLead Sponsor

1,047 Previous Clinical Trials

1,053,779 Total Patients Enrolled

2 Trials studying Adenomyosis

100 Patients Enrolled for Adenomyosis

Kimberly Kho, MDPrincipal InvestigatorUT Southwestern Medical Center

2 Previous Clinical Trials

124 Total Patients Enrolled

Media Library

RF Treatment (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05130190 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being admitted to the research project?

"Affirmative, per the information on clinicaltrials.gov this experiment is actively recruiting participants. Initially posted on July 14th 2022 and last edited a day later, it seeks to enroll 20 patients at one medical centre."

Answered by AI

Are there open slots for participants in this clinical investigation?

"Affirmative. Clinicaltrials.gov provides evidence that this specialist study, which was made available on July 14th 2022, is currently recruiting participants. It requires the recruitment of exactly 20 individuals from a single healthcare centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Radiofrequency Ablation of Adenomyosis

Kimberly Kho 2022. "Radiofrequency Ablation of Adenomyosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05130190.