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

Laparoscopic Hysterectomy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05645809
• Other study ID #: MF_PGCL_401
• Status: Recruiting
• Phase: N/A
• Start date: November 3, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: December 2022
• Source: Samyang Biopharmaceuticals Corporation
• Contact: Miryung Jin
• Phone: +82 2 2157 9961
• Email: miryung.jin[@]samyang.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 98
• Est. completion date: September 30, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Laparoscopic Hysterectomy

Intervention

Device:
• MONOFIX® PGCL
An absorbable suture made of polyglycapron (PGCL) used for soft tissue suture.
• Quill Monoderm™
An absorbable suture made of polyglactin used for soft tissue suture.

Locations

Country	Name	City	State
Korea, Republic of	Korea University Guro Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samyang Biopharmaceuticals Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time used for suturing the surgical site during laparoscopic hysterectomy	Time used from when the first suture is started to when the last suture is finished and the suture is cut	0Day