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

Sponsor
Samyang Biopharmaceuticals Corporation (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05645809
Collaborator
(none)
98
Enrollment
1
Location
2
Arms
10.9
Anticipated Duration (Months)
9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: MONOFIX® PGCL
  • Device: Quill Monoderm™
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
98 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
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
Actual Study Start Date :
Nov 3, 2022
Anticipated Primary Completion Date :
Mar 31, 2023
Anticipated Study Completion Date :
Sep 30, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Time used for suturing the surgical site during laparoscopic hysterectomy [0Day]

    Time used from when the first suture is started to when the last suture is finished and the suture is cut

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Korea University Guro Hospital Seoul Korea, Republic of

Sponsors and Collaborators

  • Samyang Biopharmaceuticals Corporation

Investigators

  • Principal Investigator: Jinhwa Hong, Korea University Guro Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Samyang Biopharmaceuticals Corporation
ClinicalTrials.gov Identifier:
NCT05645809
Other Study ID Numbers:
  • MF_PGCL_401
First Posted:
Dec 12, 2022
Last Update Posted:
Dec 12, 2022
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Dec 12, 2022