NCT05645809

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 3, 2022

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2022

Completed
25 days until next milestone

First Posted

Study publicly available on registry

December 12, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

December 12, 2022

Status Verified

December 1, 2022

Enrollment Period

5 months

First QC Date

November 17, 2022

Last Update Submit

December 7, 2022

Conditions

Laparoscopic Hysterectomy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

MONOFIX® PGCL

EXPERIMENTAL

An absorbable suture

Device: MONOFIX® PGCL

Quill Monoderm™

ACTIVE COMPARATOR

An absorbable suture

Device: Quill Monoderm™

Interventions

MONOFIX® PGCLDEVICE

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

MONOFIX® PGCL
Quill Monoderm™DEVICE

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

Quill Monoderm™

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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.)

You may not qualify if:

  • Patients with contaminated wounds
  • Diseases that may affect wound healing
  • When gynecological malignancy or intra-abdominal metastasis is confirmed at the time of enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea University Guro Hospital

Seoul, South Korea

RECRUITING

Study Officials

  • Jinhwa Hong

    Korea University Guro Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Miryung Jin

CONTACT

+82 2 2157 9961miryung.jin@samyang.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2022

First Posted

December 12, 2022

Study Start

November 3, 2022

Primary Completion

March 31, 2023

Study Completion

September 30, 2023

Last Updated

December 12, 2022

Record last verified: 2022-12

Locations

KR(1)