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

NCT ID: NCT04824430

Last Updated: 2022-06-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 36 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-23
• Study Completion Date: 2021-07-22

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

SLH 3M

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

No interventions assigned to this group

SLH 6M

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

No interventions assigned to this group

SLH 12M

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Rejoni Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cindy Basinski, MD

Role: PRINCIPAL_INVESTIGATOR

Basinski and Juran MDs

Locations

Basinksi and Juran, MD's

Newburgh, Indiana, United States

Countries

United States

Other Identifiers

EA 21-001

Identifier Type: -

Identifier Source: org_study_id