Clinical Study on a Novel Anti-adhesion Barrier Film

February 21, 2024 updated by: The Fourth Affiliated Hospital of Zhejiang University School of Medicine

A Randomized Controlled Study on an Anti-adhesion Diaphragm in Preventing Intrauterine Adhesions

The aim of this clinical study was to verify the effectiveness and safety of the anti-adhesion diaphragm in preventing intrauterine adhesions.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The main questions it aims to answer are

  • The efficacy of the anti-adhesion diaphragm in preventing intrauterine adhesions;
  • The duration of placement of the anti-adhesion septum in the uterus. Participants will be asked to place an anti-adhesion diaphragm in the uterus for 3-7 days after the abortion procedure. The control group will receive conventional treatment with no other interventions.

The researchers will compare the two groups to see if it is effective in clinical practice.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1176

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Not yet recruiting
        • The Affiliated Hospital of Hangzhou Normal University
        • Contact:
          • Peng Hu, Doctor
          • Phone Number: 13758195580
      • Lishui, Zhejiang, China, 323006
        • Not yet recruiting
        • Lishui Hospital of TCM
        • Contact:
          • Xuefang Lin, Doctor
          • Phone Number: 18957099226
      • Lishui, Zhejiang, China, 323006
        • Not yet recruiting
        • Lishui People's Hospital
        • Contact:
          • Yongju Ye, Doctor
          • Phone Number: 18957066129
      • Quzhou, Zhejiang, China, 324000
        • Not yet recruiting
        • Quzhou People's Hospital
        • Contact:
          • Yimei Ji, Doctor
          • Phone Number: 15606705252
      • Quzhou, Zhejiang, China, 324022
        • Not yet recruiting
        • The Second People's Hospital Of Quzhou, Zhejiang
        • Contact:
          • Xiaoqing Fang, Doctor
          • Phone Number: 15505708096
      • Wenzhou, Zhejiang, China, 325000
        • Not yet recruiting
        • Wenzhou Central Hospital
        • Contact:
          • Yuhong Yan, PhD
          • Phone Number: 13867701221
      • Yiwu, Zhejiang, China, 322000
        • Recruiting
        • The Fourth Affiliated Hospital Zhejiang University School of Medicine
        • Contact:
      • Yuyao, Zhejiang, China, 315400
        • Not yet recruiting
        • Yuyao People's Hospital of Zhejiang Province
        • Contact:
          • Jianting Ma, Doctor
          • Phone Number: 13805802310

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Voluntarily participate in this trial and sign a written informed consent;
  • Women aged 18 ≤ age ≤ 40 years;
  • Those who had an abortion in early pregnancy, and those who had a cleanse.

Exclusion Criteria:

  • Patients with scars;
  • Patients with allergies;
  • Patients with acute genitourinary tract infections;
  • Patients with abnormalities of reproductive organs and abnormal uterine flexion after cesarean section;
  • Patients with decreased menstrual flow after previous curettage;
  • Patients with previous suspected or diagnosed uterine adhesions;
  • Patients on immunosuppressive drugs;
  • Patients with long-term use of antibiotics;
  • Patients with malignant tumors of the reproductive organs;
  • Patients with uterine adenomyosis, endometriosis, and uterine fibroids;
  • Patients with severe systemic diseases;
  • Patients with other conditions that are not suitable.

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: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: anti-adhesion diaphragm
Participants will be asked to place an anti-adhesion diaphragm in the uterus for 3-7 days after the abortion procedure.
Device: anti-adhesion diaphragm
Participants will be asked to place an anti-adhesion diaphragm in the uterus for 3-7 days after the abortion procedure.
No Intervention: control group
Participants will be treated routinely with no other interventions.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of uterine adhesions in the 3rd postoperative menstrual cycle.
Time Frame: one week before the third menstrual cycle post-index procedure
The incidence of uterine adhesions was defined as the incidence of uterine adhesions in the control group of subjects with the uterine anti-adhesion septum placed to block the anterior and posterior uterine wall contact, and the incidence of adhesions in both groups was evaluated by ultrasound and/or hysteroscopy in the 3rd postoperative menstrual cycle.
one week before the third menstrual cycle post-index procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
bleeding volume (Normal, decrease, increase)
Time Frame: two week, three months (third menstrual cycle) post-index procedure
Menstruation
two week, three months (third menstrual cycle) post-index procedure
Postoperative Menstrual time（days）
Time Frame: two week, three months (third menstrual cycle) post-index procedure
Postoperative Menstrual time（days）
two week, three months (third menstrual cycle) post-index procedure
Abdominal pain
Time Frame: two week, three months (third menstrual cycle) post-index procedure
Abdominal pain due to postoperative menstruation
two week, three months (third menstrual cycle) post-index procedure
Physician satisfaction checklist
Time Frame: three months (third menstrual cycle) post-index procedure
classified as very satisfied, satisfied, general and unsatisfied;
three months (third menstrual cycle) post-index procedure
Patient acceptance chaecklist
Time Frame: three months (third menstrual cycle) post-index procedure
willingness to use again and to recommend others;
three months (third menstrual cycle) post-index procedure
Patient comfort after placement checklist
Time Frame: three months (third menstrual cycle) post-index procedure
classified as comfortable, general, uncomfortable, and very uncomfortable.
three months (third menstrual cycle) post-index procedure

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
body temperature ( ℃)
Time Frame: three months (third menstrual cycle) post-index procedure
Vital signs
three months (third menstrual cycle) post-index procedure
breathing (Times/minute)
Time Frame: three months (third menstrual cycle) post-index procedure
Vital signs
three months (third menstrual cycle) post-index procedure
blood pressure (mmHg)
Time Frame: three months (third menstrual cycle) post-index procedure
Vital signs
three months (third menstrual cycle) post-index procedure
heart rate ( Times/minute)
Time Frame: three months (third menstrual cycle) post-index procedure
Vital signs
three months (third menstrual cycle) post-index procedure
Number of Participants With Abnormal Laboratory Values
Time Frame: three months (third menstrual cycle) post-index procedure
Abnormal Laboratory Values
three months (third menstrual cycle) post-index procedure
adverse reactions or adverse events
Time Frame: three months (third menstrual cycle) post-index procedure
adverse events
three months (third menstrual cycle) post-index procedure

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Jian Xu, PhD, The Fourth Affiliated Hospital Zhejiang University School of Medicine

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • K2023016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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