NCT04824430

Assessment of Uterine Access, Uterine Patency and Intrauterine Adhesions Following Endometrial Ablation

Assessment of Uterine Access, Uterine Patency and Intrauterine Adhesions (IUA) 3, 6 and 12 Months Following Endometrial Ablation: A Prospective Single-Center Observational Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 36 (actual)
• Sponsor: Rejoni Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to gain information concerning the acute and longer-term morphological changes within the uterus following endometrial ablation. Hysteroscopic evaluation of the uterine cavity will be used to determine if physical access and the ability to systematically assess the post-ablation uterine cavity were preserved. The presence, location and severity of intrauterine adhesions will be documented in participants who are 3, 6 and 12 months from their standard of care endometrial ablation.

Detailed description

Prospective single center observational study. Up to 30 subjects will be enrolled (up to 10 subjects per time point). Patients who sign the Institutional Review Board (IRB) approved consent form who have undergone endometrial ablation within the prior 14 months from time of consent will be asked to participate in this study. Patients meeting all eligibility criteria will undergo either a 3, 6 or 12 month diagnostic second look hysteroscopy (SLH) as assigned by the Investigator depending on the duration of time between the ablation and the signature date of the informed consent (up to 10 subjects for each time point). A diagnostic SLH will be performed for scoring of intrauterine adhesions by the investigator and an independent reviewer. The ability to access the uterine cavity (or not) will be documented.

Conditions

• Intrauterine Adhesion

Timeline

• Start date: 2021-03-23
• Primary completion: 2021-07-22
• Completion: 2021-07-22
• First posted: 2021-04-01
• Last updated: 2022-06-16

Locations

1 site across 1 country: United States