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

Primary Purpose

Intrauterine Adhesion

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Intrauterine Biological Barrier
Intrauterine Adhesion Barrier Gel
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intrauterine Adhesion focused on measuring Endometrium, Adhesion, Postoperative adhesion, Hysteroscopy, Biological Barrier, Adhesion prevention, Infertility, Hysteroscopic Adhesiolysis

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Anhui Provincial Hosptial
  • Beijing Tiantan Hospital, Capital Medical UniversityRecruiting
  • Zhangzhou Municipal Hospital of Fujian Province
  • Guangzhou First people's Hospital
  • Suzhou Municipal Hospital
  • Tangdu Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Group

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Effective rate
At second-look hysteroscopy after Hysteroscopic adhesiolysis, the effective rate (%) = (number of cured + number of apparent effect)/total number in the group × 100%

Secondary Outcome Measures

Recurrence rate of adhesions
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%
Extent of uterine adhesions
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
Endometrial improvement
Endometrial thickness in millimeter and change values in millimeter by Ultrasonic Diagnostic Equipment Transvaginal Ultrasonic Probe Head at screening and visit 4
Time of menstrual recovery
Time to first menstruation after Hysteroscopic adhesiolysis
Duration of Menstrual recovery
Days of menstrual duration
Menstrual blood volume
Record and evaluate by Pictorial Blood Loss Assessment Chart (PBAC)
Pregnancy rate after operation 1year
Pregnancy rate (%) = number of pregnancies in the group/total number in the group × 100%

Full Information

First Posted
June 7, 2022
Last Updated
July 23, 2022
Sponsor
Beijing Tiantan Hospital
Collaborators
Zhangzhou Municipal Hospital of Fujian Province, Guangzhou First People's Hospital, Tang-Du Hospital, Suzhou Municipal Hospital, Anhui Provincial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05475756
Brief Title
Safety and Efficacy of Intrauterine Biological Barrier on Postoperative Adhesion After Hysteroscopic Adhesiolysis
Official Title
Safety and Efficacy of Intrauterine Biological Barrier on Postoperative Adhesion After Hysteroscopic Adhesiolysis: a Prospective, Multicentre, Randomized, Positive Parallel Controlled, Non-inferiority, Clinical Trail
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 25, 2022 (Actual)
Primary Completion Date
May 24, 2024 (Anticipated)
Study Completion Date
May 23, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital
Collaborators
Zhangzhou Municipal Hospital of Fujian Province, Guangzhou First People's Hospital, Tang-Du Hospital, Suzhou Municipal Hospital, Anhui Provincial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrauterine Adhesion
Keywords
Endometrium, Adhesion, Postoperative adhesion, Hysteroscopy, Biological Barrier, Adhesion prevention, Infertility, Hysteroscopic Adhesiolysis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
264 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Intrauterine Biological Barrier
Intervention Description
after Hysteroscopic adhesiolysis，use of Intrauterine Biological Barrier to repair uterine cavity
Intervention Type
Device
Intervention Name(s)
Intrauterine Adhesion Barrier Gel
Intervention Description
after Hysteroscopic adhesiolysis，use of Intrauterine Adhesion Barrier Gel to repair uterine cavity
Primary Outcome Measure Information:
Title
Effective rate
Description
At second-look hysteroscopy after Hysteroscopic adhesiolysis, the effective rate (%) = (number of cured + number of apparent effect)/total number in the group × 100%
Time Frame
Day 73±12
Secondary Outcome Measure Information:
Title
Recurrence rate of adhesions
Description
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%
Time Frame
Day 73±12
Title
Extent of uterine adhesions
Description
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
Time Frame
Day 73±12
Title
Endometrial improvement
Description
Endometrial thickness in millimeter and change values in millimeter by Ultrasonic Diagnostic Equipment Transvaginal Ultrasonic Probe Head at screening and visit 4
Time Frame
Day -7 to day 1, Day 100±10
Title
Time of menstrual recovery
Description
Time to first menstruation after Hysteroscopic adhesiolysis
Time Frame
Day 73±12
Title
Duration of Menstrual recovery
Description
Days of menstrual duration
Time Frame
Day 73±12, Day 100±10 , Day 180±30, Day 360±30
Title
Menstrual blood volume
Description
Record and evaluate by Pictorial Blood Loss Assessment Chart (PBAC)
Time Frame
Day 73±12, Day 100±10 , Day 180±30, Day 360±30
Title
Pregnancy rate after operation 1year
Description
Pregnancy rate (%) = number of pregnancies in the group/total number in the group × 100%
Time Frame
Day 360±30

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Limin Feng
Phone
18911281961
Email
Lucyfeng1966@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Limin Feng
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anhui Provincial Hosptial
City
Hefei
State/Province
Anhui
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ting Gao
First Name & Middle Initial & Last Name & Degree
Ting Gao
Facility Name
Beijing Tiantan Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qi Zhang
First Name & Middle Initial & Last Name & Degree
Qi Zhang
First Name & Middle Initial & Last Name & Degree
Limin Feng
Facility Name
Zhangzhou Municipal Hospital of Fujian Province
City
Zhangzhou
State/Province
Fujian
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feifeng Shi
First Name & Middle Initial & Last Name & Degree
Feifeng Shi
First Name & Middle Initial & Last Name & Degree
Caixia Hong
Facility Name
Guangzhou First people's Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hao Zhang
First Name & Middle Initial & Last Name & Degree
Hao Zhang
First Name & Middle Initial & Last Name & Degree
Xiaofeng Zeng
Facility Name
Suzhou Municipal Hospital
City
Suzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shunyu Hou
First Name & Middle Initial & Last Name & Degree
Shunyu Hou
Facility Name
Tangdu Hospital
City
Xi'an
State/Province
Shanxi
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xifeng Xiao
First Name & Middle Initial & Last Name & Degree
Xifeng Xiao
First Name & Middle Initial & Last Name & Degree
Wanlin Zhang

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No data sharing, only data collection and filling into paper CRF by each site
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Safety and Efficacy of Intrauterine Biological Barrier on Postoperative Adhesion After Hysteroscopic Adhesiolysis

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