Radiofrequency Ablation of Adenomyosis (NCT05130190) | Clinical Trial Compass
CompletedNot Applicable
Radiofrequency Ablation of Adenomyosis
United States15 participantsStarted 2022-07-14
Plain-language summary
To observe the effects of radiofrequency ablation on adenomyosis through the pathological analysis of treated tissue that has been removed during planned hysterectomy.
Who can participate
Age range18 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* planning to undergo an abdominal, laparoscopic, or robotic-assisted hysterectomy due to benign conditions
* uterus \< 16 weeks gestational size if undergoing a laparoscopic or robotic procedure (no size limit for patients planning to undergo a transabdominal hysterectomy)
* at least one area of focal or diffuse adenomyosis or adenomyomas that is/are contralateral to any fibroids as determined by MRI
* able to provide informed consent
* suitable candidates for surgery (have passed a standard pre-operative health assessment)
* English speaking
Exclusion Criteria:
* require emergent hysterectomy or vaginal hysterectomy
* have a uterus \> 16 weeks gestational size if undergoing a laparoscopic or robotic procedure (no size limit for patients planning to undergo a transabdominal hysterectomy)
* have fibroids in the proximity of the target adenomyosis (same side, similar location)
* are not appropriate surgical candidates as determined during pre-operative health assessment
* are unable or unwilling to undergo a hysterectomy
* are pregnant or lactating
* are under the age of 18 years
* have active pelvic inflammatory disease
* have a history of gynecologic malignancy within the past 3 years
* are unable to give informed consent
* have an implantable uterine or fallopian tube device for contraception
* are not English speaking
What they're measuring
1
Post-operative Evidence of Adenomyoma Tissue Ablation Effect by Area (n) as Assessed by Pathological Analysis
Timeframe: Post-intervention (i.e., within 4 hours of RF (radiofrequency) treatment and 2 hours of completion of hysterectomy)
Trial details
NCT IDNCT05130190
SponsorUniversity of Texas Southwestern Medical Center