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

Last updated: December 7, 2022
Sponsor: Samyang Biopharmaceuticals Corporation
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05645809
MF_PGCL_401
  • Ages > 19
  • Female

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 timeof enrollment

Study Design

Total Participants: 98
Study Start date:
November 03, 2022
Estimated Completion Date:
September 30, 2023

Connect with a study center

  • Korea University Guro Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

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