- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03007654
Evaluate Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®) (antiadhesion)
January 3, 2017 updated by: Yong Sang Song
Evaluate Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®) for Intraperitoneal Adhesion in Patient With Gynecological Surgery, a Multicenter Single-blinded, Randomized Study
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
192
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yongsang Song, MD
- Phone Number: +82-10-9580-1023
- Email: yssong@snu.ac.kr
Study Contact Backup
- Name: Maria Lee, MD
- Phone Number: +82-10-2991-9692
- Email: marialee@snu.ac.kr
Study Locations
-
-
-
Seoul City, Korea, Republic of
- Recruiting
- Seoutl National University Hospital
-
Contact:
- Maria Lee, MD
- Phone Number: +82-10-2991-9692
- Email: marialee@snu.ac.kr
-
Contact:
- Yong sang Song, MD
- Phone Number: +82-10-9580-1023
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Patients with Gynecological disease (benign disease)
- Patients who Written informed consent
- Patients without clinically significant lab
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mediclore
adhesion barrier Mediclore 5cc, to apply medical device fully around surgery area
|
apply medical device fully around intrauterine surgery area
Other Names:
|
No Intervention: No treatment
standard treatment for surgery
|
|
Active Comparator: Adept
adhesion barrier, Adept, to apply medical device fully around surgery area
|
apply medical device fully around intrauterine surgery area
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
adhesion rate
Time Frame: 4 weeks after surgery
|
4 weeks after surgery, finding adhesion using visceral slide test
|
4 weeks after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of adhesion symptoms
Time Frame: 4 weeks after surgery
|
4 weeks after surgery, Identifying adhesion sysmptoms using Questionnaire
|
4 weeks after surgery
|
adverse event
Time Frame: 4 weeks after surgery
|
identifying adverse events after surgery
|
4 weeks after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2016
Primary Completion (Anticipated)
July 1, 2017
Study Completion (Anticipated)
August 1, 2017
Study Registration Dates
First Submitted
December 30, 2016
First Submitted That Met QC Criteria
December 30, 2016
First Posted (Estimate)
January 2, 2017
Study Record Updates
Last Update Posted (Estimate)
January 5, 2017
Last Update Submitted That Met QC Criteria
January 3, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CG-AHS008
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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