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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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 20
Maximum Age: 40
Healthy Volunteers: f
View:

• Patients clinically diagnosed with intrauterine adhesions and with surgical indications (referring to those with fertility requirements or obstructed menstrual blood drainage) ② Women aged 20-40 years old; ③ Subjects voluntarily participated in the trial and signed informed consent.

Locations
Other Locations
China
The Third Xiangya Hospital of Central South University
RECRUITING
Changsha
Contact Information
Primary
Dabao MD
forxudabao@126.com
13017386201
Time Frame
Start Date: 2021-01-01
Estimated Completion Date: 2031-12-31
Participants
Target number of participants: 200
Treatments
Experimental: Experimental group
Uterine stent placement in the uterine cavity after hysteroscopic intrauterine adhesion separation surgery
Experimental: Control group
Uterine cavity insertion ring + balloon + sodium hyaluronate gel
Related Therapeutic Areas
Sponsors
Collaborators: The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, Hunan Haokang Medical Technology Co., Ltd., Beijing Tiantan Hospital
Leads: The Third Xiangya Hospital of Central South University

This content was sourced from clinicaltrials.gov