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

NCT04824430 | Completed

• 1 other identifier: EA 21-001
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intrauterine Adhesion

Outcome Measures

Primary Outcomes (1)

• Incidence of Intrauterine Adhesions (IUA)

  3, 6 or 12 months post-ablation

Study Arms (3)

SLH 3M

Second look hysteroscopy (SLH) performed 3 months post-ablation

SLH 6M

Second look hysteroscopy (SLH) performed 6 months post-ablation

SLH 12M

Second look hysteroscopy (SLH) performed 12 months post-ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women who meet eligibility criteria having undergone a prior endometrial ablation 3, 6 or 12 months prior to the second look hysteroscopy

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

Sponsors & Collaborators

• Rejoni Inc.: lead

Study Sites (1)

Basinksi and Juran, MD's

Newburgh, Indiana, 47630, United States

Location

MeSH Terms

Conditions

Gynatresia

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Cindy Basinski, MD

  Basinski and Juran MDs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: April 1, 2021
• Study Start: March 23, 2021
• Primary Completion: July 22, 2021
• Study Completion: July 22, 2021
• Last Updated: June 16, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)