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To Evaluate the Safety and Effectiveness of Intrauterine Adhesion Preventer in the Prevention and Treatment of Intrauterine Adhesions, a Prospective, Multicenter, Randomized Controlled Clinical Trial

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
To evaluate the effect of uterine stents in preventing intrauterine adhesions after intrauterine operation and whether they meet the safety requirements for clinical use. The trial adopted a prospective, multicenter, randomized controlled, non-inferiority clinical trial design. The target population of the trial was 200 women aged 20-40 years with intrauterine adhesions and surgical indications (referring to those with fertility requirements or menstrual blood drainage obstruction), who were randomly divided into an experimental group and a control group, with 100 cases in each group. The experimental group was the group with intrauterine stents placed in the uterine cavity after hysteroscopic intrauterine adhesion separation surgery, and the control group was the group with intrauterine rings + balloons + sodium hyaluronate gel placed in the uterine cavity. After 3 courses of artificial cycles, the patients were hospitalized for hysteroscopy review.
Trial Details
NCT Number NCT07611474
Lead Sponsor The Third Xiangya Hospital of Central South University
Collaborators: Hunan Haokang Medical Technology Co., Ltd., Beijing Tiantan Hospital, The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Conditions
(from sponsor)		 Intrauterine Adhesion, Intrauterine Adhesions
Related terms Gynatresia
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov