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N/A N=15 Other

Radiofrequency Ablation of Adenomyosis

Adenomyosis

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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