Clinical Trial to Evaluate the Safety and Efficacy of MON... | NCT05645809

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

NCT05645809

Sponsor

Samyang Biopharmaceuticals Corporation

Status

Unknown status

Last Update Posted

Dec 12, 2022Actual

Enrollment

98Estimated

Phase

Not Applicable

Conditions

Laparoscopic Hysterectomy

Interventions

MONOFIX® PGCL
Quill Monoderm™

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 3, 2022Actual

Primary Completion Date

Mar 31, 2023Estimated

Completion Date

Sep 30, 2023Estimated

First Submitted Date

Nov 17, 2022

First Submission Date that Met QC Criteria

Dec 7, 2022

First Posted Date

Dec 12, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 7, 2022

Last Update Posted Date

Dec 12, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

98Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MONOFIX® PGCL	Experimental	An absorbable suture	Device: MONOFIX® PGCL
Quill Monoderm™	Active Comparator	An absorbable suture	Device: Quill Monoderm™

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MONOFIX® PGCL	Device	An absorbable suture made of polyglycapron (PGCL) used for soft tissue suture.	MONOFIX® PGCL

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Miryung Jin	Contact	+82 2 2157 9961		miryung.jin@samyang.com

Overall Officials

Name	Affiliation	Role
Jinhwa Hong	Korea University Guro Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Korea University Guro Hospital	Recruiting	Seoul			South Korea