N/A
N=15
Radiofrequency Ablation of Adenomyosis
Adenomyosis
Bottom Line
View on ClinicalTrials.gov: NCT05130190 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Post-operative Evidence of Adenomyoma Tissue Ablation Effect by Area (n) as Assessed by Pathological Analysis — 9; 8; 7; 6 treated areas
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- RF Treatment (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Jan 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-operative Evidence of Adenomyoma Tissue Ablation Effect by Area (n) as Assessed by Pathological Analysis |
9; 8; 7; 6; 10 | — |
Summary
To observe the effects of radiofrequency ablation on adenomyosis through the pathological analysis of treated tissue that has been removed during planned hysterectomy.
Eligibility Criteria
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)
- 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
Data sourced from ClinicalTrials.gov (NCT05130190). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.