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

Samyang Biopharmaceuticals Corporation

Status: Enrolling

Conditions: Laparoscopic Hysterectomy

Treatments: Device: Quill Monoderm™; Device: MONOFIX® PGCL

Study type: Interventional

Funder types: Industry

Identifiers

NCT05645809

MF_PGCL_401

Details and patient eligibility

About

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

Enrollment: 98 estimated patients

Sex: Female

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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98 participants in 2 patient groups

MONOFIX® PGCL

Experimental group

Description:

An absorbable suture

Treatment:

Device: MONOFIX® PGCL

Quill Monoderm™

Active Comparator group

Description:

An absorbable suture

Treatment:

Device: Quill Monoderm™