NCT04672421

Brief Summary

This study was designed to assess the safety and efficacy of MEDICURTAIN. Patients who underwent total laparoscopic hysterectomy were randomly assigned either into Medicurtain® treatment group or non-treatment control group. Adhesion formations at 8 weeks after the index surgery were compared between the two groups by using the well-defined grade scale and image recording.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

1 active site

Status
completed

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

April 18, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2012

Completed
8.6 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

1.1 years

First QC Date

November 29, 2020

Last Update Submit

September 28, 2021

Conditions

LaparoscopyTissue Adhesion, Surgery-InducedLeiomyoma of the Uterine Body

Keywords

Medicurtain®Sodium hyaluronateHydroxyethylstarchAnti-adhesion barrier

Outcome Measures

Primary Outcomes (1)

  • Comparison of the adhesion rate between the groups

    Adhesion rate = (number of subjects who developed adhesion in a group)/ (Total number of subjects for each group)

    8 weeks after surgery

Secondary Outcomes (1)

  • Comparison of adhesion grade based on the severity between the groups

    8 weeks after surgery

Other Outcomes (4)

  • The incidence rate of adverse events

    follow up to 8 weeks

  • The incidence rate of adverse device event

    follow up to 8 weeks

  • The incidence rate of serious adverse events

    follow up to 8 weeks

  • +1 more other outcomes

Study Arms (2)

Medicurtain®

EXPERIMENTAL

Treat Medicurtain® 5ml prefilled syringe after laparoscopic surgery

Device: Medicurtain®

Placebo

SHAM COMPARATOR

laparoscopic surgery

Device: Placebo

Interventions

Medicurtain®DEVICE

Anti-adhesion barrier (Medicurtain® 5ml prefilled syringe after laparoscopic surgery)

Medicurtain®
PlaceboDEVICE

No device after laparoscopic surgery

Placebo

Eligibility Criteria

Age20 Years - 80 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Woman who is between 20\~80 years of age.
  • Woman who is reserved with total laparoscopic hysterectomy like:
  • Malignant neoplasm of cervix
  • Malignant neoplasm of uterine body
  • Unspecified malignant neoplasm of cervical region
  • Other and unspecified malignant neoplasm of the female reproductive system
  • Carcinoma in situ of the cervix
  • Other and unspecified carcinoma in situ of the reproductive system Leiomyoma of the uterus
  • Other benign neoplasms of uterus
  • Neoplasm of uncertain behavior of uterus
  • Endometriosis
  • Polyp of corpus uteri
  • Other noninflammatory disorders of uterus, except cervix
  • Cervical dysplasia
  • Congenital malformations of uterus and cervix
  • +2 more criteria

You may not qualify if:

  • Presence of tumor or inflammatory disease in other organs after the laparoscopy or laparoscopic surgery
  • Subjects with a history of open surgery or laparoscopic surgery
  • Subject who is not eligible for anesthesia or re-operation due to other disease confirmed by investigator
  • Subject who is not eligible for re-operation or laparoscopy after laparoscopic surgery
  • Subjects using coagulant and subjects with lymphoid disease
  • Diabetic subjects administrating oral or parenteral glucose-lowering drugs
  • Patients with autoimmune diseases or immune disorders
  • Liver disease or kidney disease, surgical subjects including open surgery of gastrointestinal or urinary system
  • Subjects judged as inadequate by investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, Seoul Asan Medical Center Gil, Songpa-gu, South Korea

Location

MeSH Terms

Conditions

Tissue AdhesionsMyofibroma

Condition Hierarchy (Ancestors)

CicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Young-Tak Kim, MD, PhD

    Asan Medical Center, Seoul Asan Medical Center Gil, Songpa-gu, Seoul, Korea

    PRINCIPAL INVESTIGATOR

  • Tae Jin Kim, MD, PhD

    Cheil General Hospital & Women's Healthcare Center, 1-19 Mukjeong-dong, Jung-gu, Seoul, Korea

    PRINCIPAL INVESTIGATOR

  • Yong-Il Kwon, MD, PhD

    Kangdong Sacred Heart Hospital, (Gil 1dong445) 150, Seongnae-gil, Gwangsan-gu, Gwangju, Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Evaluator-blinded
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2020

First Posted

December 17, 2020

Study Start

April 18, 2011

Primary Completion

May 9, 2012

Study Completion

May 9, 2012

Last Updated

September 29, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)