Status unknownNCT02940210Updated Oct 20, 2016

Clinical Trial to Evaluate the Efficacy and Safety of Adhesion Barrier Mediclore Versus no Treatment in Patients With Total Thyroidectomy

A Phase 3 interventional study of Mediclore® (adhesion barrier) in Patients With Thyroidectomy (Scheduled), sponsored by CGBio Inc.. Status unknown at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2016-10-20.

Sponsored by CGBio Inc. · Phase 3, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Oct 2016), so the status shown — last known as Recruiting — may be out of date.

Phase: Phase 3
Study type: Interventional
Enrollment: 172
Allocation: Randomized
Ages: 20 Years and older
Sex: All

Study summary

A randomized, single-blind, multi-center, Phase III clinical trial to evaluate the efficacy and safety of adhesion barrier Mediclore versus no treatment in patients with total thyroidectomy

Conditions studied

Patients With Thyroidectomy (Scheduled)

Browse trials for

Tissue Adhesions 241

Who can participate

Ages eligible: 20 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Written informed consent
Male or female at least 20 years of age
Patients without clinically significant lab
Patients scheduled for thyroidectomy

Exclusion criteria

Exclusion Criteria:

Another clinical trials within 1 month
History of previous surgery on same position
Anticoagulant, general steroids within a week from surgery
Immunosuppression or autoimmune disease
General or local infection
Serious diseases (heart failure, renal failure, liver failure, uncontrolled hypertension, diabetes mellitus, coagulation deficiencies)
Incompatible medications
History of drug or alcohol abuse, mental disorder
Pregnant or lactating women and fertile women who is not using proper contraceptive method
History of esophagus diseases
Keloid symptoms

Study design

Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 172 participants (estimated)

Study arms

Experimental
Mediclore®
adhesion barrier Mediclore 5cc, to apply medical device fully around thyroid gland following thyroidectomy
Device: Mediclore® (adhesion barrier)
No intervention
No treatment
No treatment, standard treatment for thyroidectomy

Interventions

DeviceMediclore® (adhesion barrier)

What researchers measure

Primary outcomes

Adhesion incidence rate following 8 weeks
Time frame: 8 weeks

Study locations

1 of 1 sites recruiting

Ajou University Hospital
Su won, Gyeonggi-do, Korea, Republic of
- Ha Eun Lee · Contact · +82-31-219-4536
Recruiting

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT02940210
Lead sponsor: CGBio Inc.
Responsible party: Sponsor
First posted: Oct 20, 2016
Start date: Aug 2016
Primary completion: Mar 2017 (estimated)
Last update: Oct 20, 2016

Study contacts

Wan Huh

Contact

whuh408@daewoong.co.kr

+82-2-550-8106

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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

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Discussion

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CGBio Inc.

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