ClinicalTrials.gg
Status unknownNCT02957500antiadhesionUpdated Mar 28, 2017

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

An interventional study of Mediclore® (adhesion barrier) in Gynecologic Disease, sponsored by CGBio Inc.. Status unknown at 1 site in Korea, Republic of. Open to female participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2017-03-28.

Sponsored by CGBio Inc. · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Nov 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
198
Allocation
Randomized
Ages
19 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 20 studies in Genital Diseases, Female with a site in Korea, Republic of — none open to participants now, none under way, none of them phase 3. Genital Diseases, Female · Korea, Republic of.

Planned enrollment
Largest of 20
198 · median 79
Started
2016
with 3 others
No phase
14 of 20
none open now
Registered
10th of 20
by date
Lead sponsor
1 of 20
CGBio Inc.

Among the 20 studies in Genital Diseases, Female with a site in Korea, Republic of, this one has the largest planned enrollment, is one of 4 that started in 2016, is one of 14 with no phase, and was the 10th registered.

Genital Diseases, Female

161 studies on the registry are indexed under Genital Diseases, Female; 31 are open to participants now.

Browse Genital Diseases, Female studies →

Open to participants now

None of the 20 studies in Genital Diseases, Female with a site in Korea, Republic of is open now.

Who these studies take

Of the 21 Genital Diseases, Female studies recruiting now, 10 (48%) set no upper age limit and 11 (52%) stop at 75 or younger; 3 take children under 18; 4 take healthy volunteers.

This study: 19 Years and older · female · no healthy volunteers.

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Download CSVNarrow it in search →With an account: the 20 studies in Genital Diseases, Female with a site in Korea, Republic of as a file.
02

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.

Read the detailed description

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

03

Conditions studied

  • Gynecologic Disease
04

Who can participate

Ages eligible
19 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

  • the patients with submucosal myomas, endometrial polyps, intra-uterine adhesion, uterine septa, dysfunctional uterine bleeding
  • Written
  • Patients without lab

Exclusion criteria

Exclusion Criteria:

  • having enrolled another clinical trials within 1 month
  • or disease
  • Anticoagulant, general within a week from surgery
  • Incompatible medications
  • Serious diseases (heart failure, renal failure, liver failure, uncontrolled hypertension, diabetes mellitus, coagulation deficiencies)
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
198 participants (estimated)

Study arms

  • 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

Interventions

  • DeviceMediclore® (adhesion barrier)
06

What researchers measure

Primary outcomes

  1. Adhesion incidence rate following 4 weeks

    Time frame: 4weeks

07

Study locations

1 of 1 sites recruiting
  • CHA kangnam medical center, CHA university
    Seoul City, Korea, Republic of
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2016 (actual). Primary completion is estimated for Jun 2017, 7 months after the start.

Of 65 interventional studies with no phase under Genital Diseases, Female, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 28. This study's planned 7 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 3, 2016
First posted
Nov 6, 2016
StartActual
Nov 22, 2016
Primary completionEst.
Jun 2017
CompletionEst.
Jul 2017
Last update
Mar 28, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02957500
Lead sponsor
CGBio Inc.
Responsible party
Sponsor
First posted
Nov 6, 2016
Start date
Nov 22, 2016
Primary completion
Jun 2017 (estimated)
Completion
Jul 2017 (estimated)
Last update
Mar 28, 2017

Study contacts

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

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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