Patients With Thyroidectomy (Scheduled)Phase 3NCT02940210
Clinical Trial to Evaluate the Efficacy and Safety of Adhesion Barrier Mediclore Versus no Treatment in Patients With Total Thyroidectomy
A Phase 3 study testing Mediclore® (adhesion barrier) in people with Patients With Thyroidectomy (Scheduled), run by CGBio Inc. at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Patients With Thyroidectomy (Scheduled)
- What is being tested?
- Mediclore® (adhesion barrier)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2016to Mar 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Male or female at least 20 years of age
- Patients without clinically significant lab
- Patients scheduled for thyroidectomy
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Ajou University Hospital
Suwon, Gyeonggi-do
Ha Eun Lee, +82-31-219-4536
About this study
Official title: A Randomized, Single-blind, Multi-center, Phase III Clinical Trail to Evaluate the Efficacy and Safety of Adhesion Barrier Mediclore Versus no Treatment in Patients With Total Thyroidectomy
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
- Patients With Thyroidectomy (Scheduled)
- Being tested
- Mediclore® (adhesion barrier)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediclore® (adhesion barrier)Device
| Study group | Role | What they receive |
|---|---|---|
| Mediclore® | Experimental | adhesion barrier Mediclore 5cc, to apply medical device fully around thyroid gland following thyroidectomy Receives: Device: Mediclore® (adhesion barrier) |
| No treatment | No intervention | No treatment, standard treatment for thyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adhesion incidence rate following 8 weeks
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2016 (estimated)
- Study startAug 2016
- Primary completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Thyroidectomy (Scheduled)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CGBio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02940210
- Sponsor's protocol ID
- CG-AHS004
- Status last verified
- Oct 2016
- First submitted
- 19 Oct 2016
- Last updated
- 20 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-blind, Multi-center, Phase III Clinical Trail to Evaluate the Efficacy and Safety of Adhesion Barrier Mediclore Versus no Treatment in Patients With Total Thyroidectomy
- ClinicalTrials.gov ID
- NCT02940210
- Acronym / sponsor ID
- CG-AHS004
- Conditions
- Patients With Thyroidectomy (Scheduled)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- CGBio Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2016
- Primary completion
- Mar 2017 (estimated)
- First posted
- 20 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mediclore® | Experimental | Device: Mediclore® (adhesion barrier)adhesion barrier Mediclore 5cc, to apply medical device fully around thyroid gland following thyroidectomy |
| No treatment | No intervention | –No treatment, standard treatment for thyroidectomy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent
- Male or female at least 20 years of age
- Patients without clinically significant lab
- Patients scheduled for thyroidectomy
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mediclore® (adhesion barrier) | Device | Mediclore® |
Primary outcome
Adhesion incidence rate following 8 weeks
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2016.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mediclore® (adhesion barrier) in people with Patients With Thyroidectomy (Scheduled), run by CGBio Inc. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wan Huh (+82-2-550-8106, whuh408@daewoong.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adhesion incidence rate following 8 weeks (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2016.