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The Efficacy and Safety of Disposable Balloon Uterine Stent in Patients With Asherman Syndrome

NCT03330873 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2017-11-06

No results posted yet for this study

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.

Conditions

  • Intrauterine Adhesion

Interventions

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.

Sponsors & Collaborators

  • Beijing Obstetrics and Gynecology Hospital

    lead OTHER

Principal Investigators

  • Duan Hua, PhD · Beijing Obstetrics and Gynecology Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-23
Primary Completion
2018-08-20
Completion
2018-10-20

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03330873 on ClinicalTrials.gov