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

Completed

Conditions studied: Intrauterine Adhesion

In brief

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.

Key facts

Study ID

NCT04824430

Run by

Rejoni Inc.

People needed

36

Starts

2021-03-23

Expected to finish

2021-07-22

Last updated by the study team

2022-06-16

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Premenopausal female patients ≥ 18 years of age
• Patient has undergone endometrial ablation within the prior 14 months.
• There were no contraindications for endometrial ablation as specified in Ablation System labeling
• Patient agrees to undergo an SLH either at 3, 6 or 12 months post-ablation
• Patient abstained from any form of hormonal contraception including an IUD after the ablation and through the period that the SLH is performed.
• Patient has signed the IRB approved informed consent.

You may not qualify if…

• Additional intrauterine procedures performed between time of endometrial ablation and the SLH; e.g., endometrial and/or myometrial resection.
• IUD in situ
• Pregnant (positive urine pregnancy test) or lactating
• Active sexually transmitted infection or genital infection, or other clinically significant active and/or systemic infection per clinical or laboratory examinations at the time of endometrial ablation procedure or second look hysteroscopy (e.g., cervicitis, vaginitis, endometritis, or salpingitis).
• Systemic steroid within 1 week of endometrial ablation
• Previous adhesiolysis procedure or diagnosis of Asherman's disease.
• No noted clinically significant uterine anomalies at the time of the ablation (e.g., septate uterus or other anomalies that distorts the uterine cavity)
• Any other condition that in the opinion of the investigator could represent an increased risk for the subject, affect the primary outcomes of this study and/or impact the subject's ability to comply with protocol requirements.
• Participating or considering participation in a clinical trial of another investigational drug or device during this study

Where it is running

• Basinksi and Juran, MD's — Newburgh, Indiana, United States

Full record on ClinicalTrials.gov

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