NCT03007654

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Mediclore®, as an antiadhesive barrier, which is made of Poloxamer, Gelatin and Chitosan.

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
192

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2016

Shorter than P25 for phase_3

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

December 1, 2016

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

December 30, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 2, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

January 5, 2017

Status Verified

January 1, 2017

Enrollment Period

7 months

First QC Date

December 30, 2016

Last Update Submit

January 3, 2017

Conditions

Gynecologic Disease

Outcome Measures

Primary Outcomes (1)

  • adhesion rate

    4 weeks after surgery, finding adhesion using visceral slide test

    4 weeks after surgery

Secondary Outcomes (2)

  • Incidence of adhesion symptoms

    4 weeks after surgery

  • adverse event

    4 weeks after surgery

Study Arms (3)

Mediclore

EXPERIMENTAL

adhesion barrier Mediclore 5cc, to apply medical device fully around surgery area

Device: Mediclore

No treatment

NO INTERVENTION

standard treatment for surgery

Adept

ACTIVE COMPARATOR

adhesion barrier, Adept, to apply medical device fully around surgery area

Device: Adept

Interventions

MedicloreDEVICE

apply medical device fully around intrauterine surgery area

Also known as: Poloxamer, Gelatin and Chitosan.
Mediclore
AdeptDEVICE

apply medical device fully around intrauterine surgery area

Adept

Eligibility Criteria

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

You may qualify if:

  • Patients with Gynecological disease (benign disease)
  • Patients who Written informed consent
  • Patients without clinically significant lab

You may not qualify if:

  • having enrolled another clinical trials within 1 month
  • Immunosuppression or autoimmune disease
  • Anticoagulant, general steroids within a week from surgery
  • Serious diseases (heart failure, renal failure, liver failure, uncontrolled hypertension, diabetes mellitus, coagulation deficiencies)
  • Patients with previous history of surgery at the same operate site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoutl National University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Genital Diseases, Female

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

Yongsang Song, MD

CONTACT

+82-10-9580-1023yssong@snu.ac.kr

Maria Lee, MD

CONTACT

+82-10-2991-9692marialee@snu.ac.kr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 30, 2016

First Posted

January 2, 2017

Study Start

December 1, 2016

Primary Completion

July 1, 2017

Study Completion

August 1, 2017

Last Updated

January 5, 2017

Record last verified: 2017-01

Locations

KR(1)