Status:
COMPLETED
Assessment of Uterine Access, Uterine Patency and Intrauterine Adhesions Following Endometrial Ablation
Lead Sponsor:
Rejoni Inc.
Conditions:
Intrauterine Adhesion
Eligibility:
FEMALE
18+ years
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 ...
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 h...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 23 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 22 2021
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04824430
Start Date
March 23 2021
End Date
July 22 2021
Last Update
June 16 2022
Active Locations (1)
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1
Basinksi and Juran, MD's
Newburgh, Indiana, United States, 47630