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

NCT ID: NCT05645809

Last Updated: 2022-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-03

Study Completion Date

2023-09-30

Brief Summary

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

Detailed Description

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Conditions

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Laparoscopic Hysterectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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MONOFIX® PGCL

An absorbable suture

Group Type EXPERIMENTAL

MONOFIX® PGCL

Intervention Type DEVICE

An absorbable suture made of polyglycapron (PGCL) used for soft tissue suture.

Quill Monoderm™

An absorbable suture

Group Type ACTIVE_COMPARATOR

Quill Monoderm™

Intervention Type DEVICE

An absorbable suture made of polyglactin used for soft tissue suture.

Interventions

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MONOFIX® PGCL

An absorbable suture made of polyglycapron (PGCL) used for soft tissue suture.

Intervention Type DEVICE

Quill Monoderm™

An absorbable suture made of polyglactin used for soft tissue suture.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Samyang Biopharmaceuticals Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jinhwa Hong

Role: PRINCIPAL_INVESTIGATOR

Korea University Guro Hospital

Locations

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Korea University Guro Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Miryung Jin

Role: CONTACT

+82 2 2157 9961

Facility Contacts

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Jinhwa Hong

Role: primary

+82 2 2626 3149

Other Identifiers

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MF_PGCL_401

Identifier Type: -

Identifier Source: org_study_id

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