NCT02957500

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
198

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

November 3, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 7, 2016

Completed
15 days until next milestone

Study Start

First participant enrolled

November 22, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

March 28, 2017

Status Verified

November 1, 2016

Enrollment Period

6 months

First QC Date

November 3, 2016

Last Update Submit

March 26, 2017

Conditions

Gynecologic Disease

Outcome Measures

Primary Outcomes (1)

  • Adhesion incidence rate following 4 weeks

    4weeks

Study Arms (2)

Mediclore®

EXPERIMENTAL

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

Device: Mediclore® (adhesion barrier)

No treatment

NO INTERVENTION

standard treatment for surgery

Interventions

Mediclore® (adhesion barrier)DEVICE
Mediclore®

Eligibility Criteria

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

You may qualify if:

  • the patients with submucosal myomas, endometrial polyps, intra-uterine adhesion, uterine septa, dysfunctional uterine bleeding
  • 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
  • Incompatible medications
  • Serious diseases (heart failure, renal failure, liver failure, uncontrolled hypertension, diabetes mellitus, coagulation deficiencies)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHA kangnam medical center, CHA university

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

Jihee Jang

CONTACT

+82-2-550-8037jhchang@daewoong.co.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2016

First Posted

November 7, 2016

Study Start

November 22, 2016

Primary Completion

June 1, 2017

Study Completion

July 1, 2017

Last Updated

March 28, 2017

Record last verified: 2016-11

Locations

KR(1)