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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
Sponsor:
Information provided by (Responsible Party):
Beijing Obstetrics and Gynecology Hospital

Tracking Information
First Submitted Date  ICMJE October 18, 2017
First Posted Date  ICMJE November 6, 2017
Last Update Posted Date November 6, 2017
Actual Study Start Date  ICMJE October 23, 2017
Estimated Primary Completion Date August 20, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2017)
second diagnostic hysteroscopy [ Time Frame: Within the first 3 months after surgery ]
AFS score(The American Fertility Society classifications)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy and Safety of Disposable Balloon Uterine Stent in Patients With Asherman Syndrome
Official Title  ICMJE Randomized, Controlled Trial to Assess the Efficacy of Disposable Balloon Uterine Stent and Foley Catheter in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis
Brief Summary Asherman's syndrome is characterized by the presence of intrauterine adhesions (IUA) as well as symptoms such as amenorrhea, hypomenorrhea, pelvic pain, and infertility. The gold standard for the treatment of intrauterine adhesions is hysteroscopic intrauterine adhesions. The recurrence of intrauterine adhesions is a major challenge in clinical practice. The isolation of barriers in the uterine cavity may be a measure to reduce postoperative re adhesion, but the effect of different devices is different. Therefore, this study was conducted.
Detailed Description The Foley catheter is usually inserted into the uterine after a hysteroscopic adhesiolysis and removed after on the 5-7th day after surgery. Several investigators demonstrated its favorable effect in the recurrence of adhesion after the treatment of intrauterine adhesion. Disposable balloon uterine stent is specially designed to fit into the cavity of the uterus, and usually removed on the 7th day after surgery.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Intrauterine Adhesion
Intervention  ICMJE
  • 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
  • Device: Foley catheter
    Foley catheter can partly separate the sides of uterus wall.
Study Arms  ICMJE
  • 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.
    Intervention: Device: Foley catheter
  • 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.
    Intervention: Device: disposable balloon uterine stent
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 31, 2017)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 20, 2018
Estimated Primary Completion Date August 20, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03330873
Other Study ID Numbers  ICMJE No.3-20140601
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Beijing Obstetrics and Gynecology Hospital
Study Sponsor  ICMJE Beijing Obstetrics and Gynecology Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Duan Hua, PhD Beijing Obstetrics and Gynecology Hospital
PRS Account Beijing Obstetrics and Gynecology Hospital
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP