NCT02909270

Brief 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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 21, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Last Updated

September 21, 2016

Status Verified

September 1, 2016

Enrollment Period

7 months

First QC Date

September 18, 2016

Last Update Submit

September 18, 2016

Conditions

Patients With Thyroidecomy (Scheduled)

Outcome Measures

Primary Outcomes (1)

  • adhesion incidence rate following 8 weeks

    8 weeks

Study Arms (2)

Mediclore

EXPERIMENTAL

adhesion barrier Mediclore 5cc, to apply medical device fully around thyroid gland following thyroidectomy

Device: Mediclore

No treatment

NO INTERVENTION

No treatment, standard treatment for thyroidectomy

Interventions

MedicloreDEVICE

to apply mediclore fully around thyroid gland

Mediclore

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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 hypertentsion, 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ajou University Hospital

Suwon, Gyeonggi-do, South Korea

RECRUITING

Central Study Contacts

Wan Huh

CONTACT

+82-2-550-8106whuh408@daewoong.co.kr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2016

First Posted

September 21, 2016

Study Start

August 1, 2016

Primary Completion

March 1, 2017

Last Updated

September 21, 2016

Record last verified: 2016-09

Locations

KR(1)