The Efficacy and Safety of Disposable Balloon Uterine Stent in Patients With Asherman Syndrome
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ClinicalTrials.gov Identifier: NCT03330873 |
Recruitment Status : Unknown
Verified October 2017 by Beijing Obstetrics and Gynecology Hospital.
Recruitment status was: Recruiting
First Posted : November 6, 2017
Last Update Posted : November 6, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Intrauterine Adhesion | Device: disposable balloon uterine stent Device: Foley catheter | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Randomized, Controlled Trial to Assess the Efficacy of Disposable Balloon Uterine Stent and Foley Catheter in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis |
Actual Study Start Date : | October 23, 2017 |
Estimated Primary Completion Date : | August 20, 2018 |
Estimated Study Completion Date : | October 20, 2018 |
Arm | Intervention/treatment |
---|---|
Experimental: Foley catheter
After the completion of hysteroscopic adhesiolysis, Foley catheter was inserted and inflated with normal saline which was removed on the 7th day after surgery.
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Device: Foley catheter
Foley catheter can partly separate the sides of uterus wall. |
Experimental: Disposable balloon uterine stent
After the completion of hysteroscopic adhesiolysis, disposable balloon uterine stent was inserted and inflated with normal saline which was removed on the 7th day after surgery.
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Device: disposable balloon uterine stent
The disposable balloon uterine stent is heart-shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to Foley catheter |
- second diagnostic hysteroscopy [ Time Frame: Within the first 3 months after surgery ]AFS score(The American Fertility Society classifications)
- Menstruation Pattern [ Time Frame: Within the first 3 months after surgery ]Improvement or No Significant Change
- Number of participants with pregnancy [ Time Frame: one year ]Number of biochemical pregnancies and clinical pregnancies

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Ages Eligible for Study: | 20 Years to 40 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- age 20-40 years;
- Moderate to severe intrauterine adhesion (AFS score ≥5);
- complains of menstruation disorder and reproductive dysfunction
- Agreement to have second-look hysteroscopy
- informed consent
Exclusion Criteria:
- ovarian failure
- patients who did not proceed to second-look hysteroscopy within the specified time frame
- Contraindication of hormone

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03330873
Contact: Zhu Ru, MD | +8613966636438 | zhuru19790202@163.com | |
Contact: Wang Sha, MD | +8615201556908 | wangsha1020@163.com |
China, Beijing | |
Beijing Obstetrics and Gynecology Hospital,Capital Medical University | Recruiting |
Beijing, Beijing, China, 100006 | |
Contact: Liu Zhen +8613718210767 fcyykyb@163.com |
Study Chair: | Duan Hua, PhD | Beijing Obstetrics and Gynecology Hospital |
Responsible Party: | Beijing Obstetrics and Gynecology Hospital |
ClinicalTrials.gov Identifier: | NCT03330873 |
Other Study ID Numbers: |
No.3-20140601 |
First Posted: | November 6, 2017 Key Record Dates |
Last Update Posted: | November 6, 2017 |
Last Verified: | October 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Asherman syndrome disposable balloon uterine stent hysteroscopy Foley catheter |
Tissue Adhesions Cicatrix Fibrosis Pathologic Processes |