Safety and Efficacy of Intrauterine Biological Barrier on Postoperative Adhesion After Hysteroscopic Adhesiolysis

July 23, 2022 updated by: Limin Feng, Beijing Tiantan Hospital

Safety and Efficacy of Intrauterine Biological Barrier on Postoperative Adhesion After Hysteroscopic Adhesiolysis: a Prospective, Multicentre, Randomized, Positive Parallel Controlled, Non-inferiority, Clinical Trail

To evaluate the safety and efficacy of Intrauterine Biological Barrier developed and produced by Chengdu TopRegMed Medical Technology Co., Ltd on postoperative adhesion after Hysteroscopic Adhesiolysis.

Study Overview

Detailed Description

This study is a prospective, multicenter, randomized, parallel positive-control, non-inferior clinical trial, with the purpose to evaluate the efficacy and safety of Intrauterine Biological Barrier for the prevention or reduction of intrauterine adhesions after Hysteroscopic Adhesiolysis.

The trial will be conducted at six clinical centers with 264 subjects who meet all the inclusion/ exclusion criteria. Subjects will be randomly assigned to the experimental group and the control group in a 1:1 ratio. Subjects in the test group were treated with Intrauterine Biological Barrier (IBB) made by Chengdu TopRegMed Medical Technology Co. , Ltd. , while the patients in the positive control group were treated with commercially approved Intrauterine Adhesion Barrier Gel for uterine cavity made by Changzhou Bioregen biopharmaceutical Co. , Ltd. .

Subjects will be followed up for 12 months (360 days ± 30 days) after implantation. 73-days (± 12 days) after operation, the safety and effectiveness of IBB will be evaluated by demonstrating non-inferiority to commercially approved gel. If test group is non-inferiority, further study will be performed to explore whether the safety and effectiveness of the IBB is better than the control group in the aspect of the recurrence rate of intrauterine adhesion, types of intrauterine adhesion, postoperative endometrial repair, menstrual recovery and 1-year pregnancy rate.

Study Type

Interventional

Enrollment (Anticipated)

264

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Anhui
      • Hefei, Anhui, China
        • Not yet recruiting
        • Anhui Provincial Hosptial
        • Contact:
          • Ting Gao
        • Principal Investigator:
          • Ting Gao
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Beijing Tiantan Hospital, Capital Medical University
        • Contact:
          • Qi Zhang
        • Sub-Investigator:
          • Qi Zhang
        • Principal Investigator:
          • Limin Feng
    • Fujian
      • Zhangzhou, Fujian, China
        • Not yet recruiting
        • Zhangzhou Municipal Hospital of Fujian Province
        • Contact:
          • Feifeng Shi
        • Principal Investigator:
          • Feifeng Shi
        • Sub-Investigator:
          • Caixia Hong
    • Guangdong
      • Guangzhou, Guangdong, China
        • Not yet recruiting
        • Guangzhou First People's Hospital
        • Principal Investigator:
          • Hao Zhang
        • Contact:
          • Hao Zhang
        • Sub-Investigator:
          • Xiaofeng Zeng
    • Jiangsu
      • Suzhou, Jiangsu, China
        • Not yet recruiting
        • Suzhou Municipal Hospital
        • Contact:
          • Shunyu Hou
        • Principal Investigator:
          • Shunyu Hou
    • Shanxi
      • Xi'an, Shanxi, China
        • Not yet recruiting
        • Tangdu Hospital
        • Contact:
          • Xifeng Xiao
        • Principal Investigator:
          • Xifeng Xiao
        • Sub-Investigator:
          • Wanlin Zhang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • (1)Age, yr20-40 (including boundary value), Female
  • (2)Normal ovarian reserve function (FSH<10U/ml,AMH>2ng/ml)
  • (3)Who suffered from moderate to severe intrauterine adhesions (AFS ≥ 5 points) diagnosed by hysteroscopy, and prepared to be treated by Hysteroscopic adhesiolysis
  • (4)Both husband and wife have fertility intention during treatment
  • (5)Accept to treatment and follow-up visits, Sign the ICF

Exclusion Criteria:

  • (1)Severe systemic diseases, contraindications of surgical and cycle
  • (2)Inflammation of reproductive tract, genital tuberculosis, pelvic infection, tumor of reproductive organs
  • (3)Systemic diseases cause uterine bleeding
  • (4)Allergic to hyaluronic acid or components
  • (5)Allergic to swine sources medical device, or refuse to swine sources medical device for religious, ethnic and other reasons
  • (6)Insufficient uterine cavity volume after Hysteroscopic adhesiolysis to place Intrauterine Biological Barrier or inject Intrauterine Adhesion Barrier Gel
  • (7)Involved other clinical trial before Hysteroscopic adhesiolysis in 3 months or during the trail
  • (8)Unable to tolerate anesthesia
  • (9)Estrogen medicine was taken within 30 days of Hysteroscopic adhesiolysis
  • (10)Other inadequacy patient assessed by the researchers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
Material:Small intestinal submucosa Specifications:A、B、C、D、E Dosage: investigator selects the specification and quantity(dosage) according to the postoperative uterine cavity volume Frequency:one time after the operation Duration:Single-use
after Hysteroscopic adhesiolysis,use of Intrauterine Biological Barrier to repair uterine cavity
Active Comparator: Control Group
Material: auto-crosslinked HA gel Specifications: 1 ml, 1.25 ml, 1.5 ml, 1.75 ml, 2 ml, 2.25 ml, 2.5 ml, 2.75 ml, 3 ml, 3.25 ml, 3.75 ml, 4 ml, 4.25 ml, 4.5 ml, 5 ml, 6 ml, 8ml Dosage: investigator selects the specification and quantity(dosage) according to the postoperative uterine cavity volume Frequency:one time after the operation Duration:Single-use
after Hysteroscopic adhesiolysis,use of Intrauterine Adhesion Barrier Gel to repair uterine cavity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effective rate
Time Frame: Day 73±12
At second-look hysteroscopy after Hysteroscopic adhesiolysis, the effective rate (%) = (number of cured + number of apparent effect)/total number in the group × 100%
Day 73±12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence rate of adhesions
Time Frame: Day 73±12
The Presence of adhesions was determined at second-look hysteroscopy after Hysteroscopic adhesiolysis, and the recurrence rate of adhesions (%) = number of adhesion reoccurrence/total number in the group × 100%
Day 73±12
Extent of uterine adhesions
Time Frame: Day 73±12
The degree of uterine adhesions was assessed intraoperatively and at the second-look hysteroscopy with reference to the ESGE (European Society for Gynecological Endoscopy) criteria
Day 73±12
Endometrial improvement
Time Frame: Day -7 to day 1, Day 100±10
Endometrial thickness in millimeter and change values in millimeter by Ultrasonic Diagnostic Equipment Transvaginal Ultrasonic Probe Head at screening and visit 4
Day -7 to day 1, Day 100±10
Time of menstrual recovery
Time Frame: Day 73±12
Time to first menstruation after Hysteroscopic adhesiolysis
Day 73±12
Duration of Menstrual recovery
Time Frame: Day 73±12, Day 100±10 , Day 180±30, Day 360±30
Days of menstrual duration
Day 73±12, Day 100±10 , Day 180±30, Day 360±30
Menstrual blood volume
Time Frame: Day 73±12, Day 100±10 , Day 180±30, Day 360±30
Record and evaluate by Pictorial Blood Loss Assessment Chart (PBAC)
Day 73±12, Day 100±10 , Day 180±30, Day 360±30
Pregnancy rate after operation 1year
Time Frame: Day 360±30
Pregnancy rate (%) = number of pregnancies in the group/total number in the group × 100%
Day 360±30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2022

Primary Completion (Anticipated)

May 24, 2024

Study Completion (Anticipated)

May 23, 2025

Study Registration Dates

First Submitted

June 7, 2022

First Submitted That Met QC Criteria

July 23, 2022

First Posted (Actual)

July 27, 2022

Study Record Updates

Last Update Posted (Actual)

July 27, 2022

Last Update Submitted That Met QC Criteria

July 23, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No data sharing, only data collection and filling into paper CRF by each site

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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