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Status unknownNCT03007654antiadhesionUpdated Jan 5, 2017

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

A Phase 3 interventional study of Mediclore and Adept in Gynecologic Disease, sponsored by Yong Sang Song. Status unknown at 1 site in South Korea. Open to female participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2017-01-05.

Sponsored by Yong Sang Song · Phase 3, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jan 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
192
Allocation
Randomized
Ages
20 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Gynecologic Disease
03

In context

Genital Diseases, Female

158 studies on the registry are indexed under Genital Diseases, Female; 33 are open to participants now.

This study's planned enrollment of 192 is above the median of 80 across 114 interventional studies indexed under Genital Diseases, Female.

Browse Genital Diseases, Female studies →

Lead sponsor

This is the only study on the registry with Yong Sang Song as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
192 participants (estimated)

Study arms

  • Experimental
    Mediclore

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

    Device: Mediclore

  • No intervention
    No treatment

    standard treatment for surgery

  • Active comparator
    Adept

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

    Device: Adept

Interventions

  • DeviceMediclore

    apply medical device fully around intrauterine surgery area

    Also known as: Poloxamer, Gelatin and Chitosan.

  • DeviceAdept

    apply medical device fully around intrauterine surgery area

06

What researchers measure

Primary outcomes

  1. adhesion rate

    4 weeks after surgery, finding adhesion using visceral slide test

    Time frame: 4 weeks after surgery

Secondary outcomes

  1. Incidence of adhesion symptoms

    4 weeks after surgery, Identifying adhesion sysmptoms using Questionnaire

    Time frame: 4 weeks after surgery

  2. adverse event

    identifying adverse events after surgery

    Time frame: 4 weeks after surgery

07

Study locations

1 of 1 sites recruiting
  • Seoutl National University Hospital
    Seoul, South Korea
    Recruiting
    • Yong sang Song, MD · Contact+82-10-9580-1023
    • Maria Lee, MD · Contactmarialee@snu.ac.kr · +82-10-2991-9692
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03007654
Lead sponsor
Yong Sang Song
Responsible party
Yong Sang Song (MD, Seoul National University Hospital) — Sponsor-investigator
First posted
Jan 2, 2017
Start date
Dec 2016
Primary completion
Jul 2017 (estimated)
Completion
Aug 2017 (estimated)
Last update
Jan 5, 2017

Study contacts

Yongsang Song, MD
Contact
yssong@snu.ac.kr
+82-10-9580-1023
Maria Lee, MD
Contact
marialee@snu.ac.kr
+82-10-2991-9692

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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