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To Evaluate Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®) (antiadhesion)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02957500
Recruitment Status : Unknown
Verified November 2016 by CGBio Inc..
Recruitment status was:  Recruiting
First Posted : November 7, 2016
Last Update Posted : March 28, 2017
Sponsor:
Information provided by (Responsible Party):
CGBio Inc.

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.

Condition or disease Intervention/treatment Phase
Gynecologic Disease Device: Mediclore® (adhesion barrier) Not Applicable

Detailed Description:
to evaluate the efficacy and safety of Mediclore®, as an antiadhesive barrier

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: To Evaluate Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®) After Intrauterine Surgery in Patient With Gynecological Disease, a Multicenter, Randomized, Double- Blinded Study
Actual Study Start Date : November 22, 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions
Drug Information available for: Poloxamer

Arm Intervention/treatment
Experimental: Mediclore®
adhesion barrier Mediclore 5cc, to apply medical device fully around intrauterine surgery area
Device: Mediclore® (adhesion barrier)
No Intervention: No treatment
standard treatment for surgery



Primary Outcome Measures :
  1. Adhesion incidence rate following 4 weeks [ Time Frame: 4weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02957500


Contacts
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Contact: Jihee Jang +82-2-550-8037 jhchang@daewoong.co.kr

Locations
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Korea, Republic of
CHA kangnam medical center, CHA university Recruiting
Seoul City, Korea, Republic of
Contact: Seok Ju Seong       sjseongcheil@naver.com   
Sponsors and Collaborators
CGBio Inc.

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Responsible Party: CGBio Inc.
ClinicalTrials.gov Identifier: NCT02957500     History of Changes
Other Study ID Numbers: CG-AHS007
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: undecided
Additional relevant MeSH terms:
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Genital Diseases, Female
Chitosan
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Chelating Agents
Sequestering Agents
Hemostatics
Coagulants