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

Capital Medical University

Status: Enrolling

Conditions: Intrauterine Adhesion

Treatments: Device: Intrauterine Adhesion Barrier Gel; Device: Intrauterine Biological Barrier

Study type: Interventional

Funder types: Other

Identifiers

NCT05475756

RKM-GPSIS-CTP202201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 264 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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264 participants in 2 patient groups

Experimental Group

Experimental group

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

Treatment:

Device: Intrauterine Biological Barrier

Control Group

Active Comparator group

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

Treatment:

Device: Intrauterine Adhesion Barrier Gel