Clinical Trial to Evaluate the Safety and Efficacy of MONOFIX® PGCL Suture in Laparoscopic Surgery

December 7, 2022 updated by: Samyang Biopharmaceuticals Corporation

A Multicenter, Randomized, Single-blinded, Active Controlled, Non-inferiority, Post Marketing Clinical Trial to Evaluate the Safety and Efficacy of MONOFIX® PGCL Suture Compared to Quill MonodermTM Suture in Laparoscopic Surgery

Clinical Trial to Evaluate the Safety and Efficacy of MONOFIX® PGCL Suture Compared to Quill MonodermTM Suture in Laparoscopic Surgery

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

98

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

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Korea University Guro Hospital
        • Contact:
        • Principal Investigator:
          • Jinhwa Hong

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

1. Patients scheduled for hysterectomy by laparoscopic surgery

  • Patients who are scheduled to undergo hysterectomy after being diagnosed with benign tumors in the uterus, including uterine myoma, according to the medical judgment of the investigator
  • Laparoscopic surgery includes general laparoscopic surgery and robotic surgery.)

Exclusion Criteria:

  1. Patients with contaminated wounds
  2. Diseases that may affect wound healing
  3. When gynecological malignancy or intra-abdominal metastasis is confirmed at the time of enrollment

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MONOFIX® PGCL
An absorbable suture
Device: MONOFIX® PGCL
An absorbable suture made of polyglycapron (PGCL) used for soft tissue suture.
Active Comparator: Quill Monoderm™
An absorbable suture
Device: Quill Monoderm™
An absorbable suture made of polyglactin used for soft tissue suture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time used for suturing the surgical site during laparoscopic hysterectomy
Time Frame: 0Day
Time used from when the first suture is started to when the last suture is finished and the suture is cut
0Day

Collaborators and Investigators

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

Sponsor

Samyang Biopharmaceuticals Corporation

Investigators

  • Principal Investigator: Jinhwa Hong, Korea University Guro Hospital

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)

November 3, 2022

Primary Completion (Anticipated)

March 31, 2023

Study Completion (Anticipated)

September 30, 2023

Study Registration Dates

First Submitted

November 17, 2022

First Submitted That Met QC Criteria

December 7, 2022

First Posted (Estimate)

December 12, 2022

Study Record Updates

Last Update Posted (Estimate)

December 12, 2022

Last Update Submitted That Met QC Criteria

December 7, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • MF_PGCL_401

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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