Radiofrequency Ablation of Adenomyosis

Launched by UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER · Nov 10, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called radiofrequency ablation for a condition known as adenomyosis, which affects the uterus and can cause pain and heavy bleeding. The goal of the study is to see how effective this treatment is by examining the tissue that is removed during a planned hysterectomy (surgery to remove the uterus). The trial is currently looking for women, aged 65 to 74, who are planning to have this surgery for non-cancerous reasons and have been diagnosed with adenomyosis.

To be part of this study, participants need to meet certain requirements. They should be scheduled for either an abdominal, laparoscopic, or robotic-assisted hysterectomy and must have adenomyosis that is not near any existing fibroids. Additionally, they need to be healthy enough for surgery and able to understand and agree to participate. Women who are pregnant, younger than 18, or have certain health conditions are not eligible. If you join the trial, you can expect to have your tissue analyzed after the procedure to help researchers understand how well radiofrequency ablation works for treating adenomyosis.

Gender

FEMALE

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)
• • 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