AdhesionPhase 4NCT03293186
Anti-adhesive Effect and Safety of "Thermo-sensitive Adhesion Barrier (MEDICLORE)"
A Phase 4 study testing MEDICLORE in people with Adhesion and Thyroidectomy, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
One of most important complication of thyroid surgery is adhesion. There are many anti-adhesive materials, but none of them showed significant outcomes. The investigators planned double blind prospective study of "Thermo-sensitive Adhesion Barrier (MEDICLORE)" to reveal anti-adhesive effect of MEDICLORE. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Adhesion, Thyroidectomy
- What is being tested?
- MEDICLORE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2017to 31 Dec 2020
- Phase
- Phase 4
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- planned to perform thyroidectomy due to thyroid nodule
- no evidence of distant metastasis or invasion to adjacent organ in thyroid cancer
- normal preoperative vocal cord movement
- normal preoperative laboratory study
Who cannot join
- uncontrolled hypertension, diabetes, chronic renal failure, coagulopathy
- history of keloid or hypertrophic scar
- Graves disease or hashimoto thyroiditis patients
- aspirin or anticoagulant medication within 7 days
- radiation exposure to the head and neck
- previous operation to the neck
- history of allergic reaction to drugs
- pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anti-adhesive Effect and Safety of "Thermo-sensitive Adhesion Barrier (MEDICLORE)" by Using Double-blind Test in Thyroid Surgery
One of most important complication of thyroid surgery is adhesion. There are many anti-adhesive materials, but none of them showed significant outcomes. The investigators planned double blind prospective study of "Thermo-sensitive Adhesion Barrier (MEDICLORE)" to reveal anti-adhesive effect of MEDICLORE. The investigators will recruit total 90 patients (control group 45, experimental group 45) and compare postoperative outcomes about adhesion.
- Conditions
- Adhesion, Thyroidectomy
- Being tested
- MEDICLORE
- Medical subject headings
- Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDICLORECombination product
use MEDICLORE at the end of surgery as antiadhesive product
| Study group | Role | What they receive |
|---|---|---|
| Use MEDICLORE | Experimental | use mediclore at the end of surgery Receives: Combination Product: MEDICLORE |
| No antiadhesive product | No intervention | use no antiadhesive product at the end of surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of postoperative adhesion will checked using answer of questionnaire that participants and physicians replied.
Measured: Participants will be followed from the operation to postoperative 2weeks, 3months, 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start1 Jul 2017
- Primary completion27 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdhesionStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Su-jin Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03293186
- Sponsor's protocol ID
- SNUHthyroid2
- Status last verified
- Mar 2021
- First submitted
- 18 Aug 2017
- Last updated
- 17 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-adhesive Effect and Safety of "Thermo-sensitive Adhesion Barrier (MEDICLORE)" by Using Double-blind Test in Thyroid Surgery
- ClinicalTrials.gov ID
- NCT03293186
- Acronym / sponsor ID
- SNUHthyroid2
- Conditions
- Adhesion, Thyroidectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 27 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 26 Sep 2017 (actual)
- 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.
One of most important complication of thyroid surgery is adhesion. There are many anti-adhesive materials, but none of them showed significant outcomes. The investigators planned double blind prospective study of "Thermo-sensitive Adhesion Barrier (MEDICLORE)" to reveal anti-adhesive effect of MEDICLORE. The investigators will recruit total 90 patients (control group 45, experimental group 45) and compare postoperative outcomes about adhesion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Use MEDICLORE | Experimental | Combination Product: MEDICLOREuse mediclore at the end of surgery |
| No antiadhesive product | No intervention | –use no antiadhesive product at the end of surgery |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- planned to perform thyroidectomy due to thyroid nodule
- no evidence of distant metastasis or invasion to adjacent organ in thyroid cancer
- normal preoperative vocal cord movement
- normal preoperative laboratory study
Key exclusion criteria (8 listed)
- uncontrolled hypertension, diabetes, chronic renal failure, coagulopathy
- history of keloid or hypertrophic scar
- Graves disease or hashimoto thyroiditis patients
- aspirin or anticoagulant medication within 7 days
- radiation exposure to the head and neck
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 |
|---|---|---|
| MEDICLOREuse MEDICLORE at the end of surgery as antiadhesive product | Combination product | Use MEDICLORE |
Primary outcome
Changes of postoperative adhesion will checked using answer of questionnaire that participants and physicians replied.
Time frame: Participants will be followed from the operation to postoperative 2weeks, 3months, 6months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MEDICLORE in people with Adhesion and Thyroidectomy, run by Seoul National University Hospital 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 8 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: finished, as of the sponsor's last update on 17 Mar 2021. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of postoperative adhesion will checked using answer of questionnaire that participants and physicians replied. (time frame: Participants will be followed from the operation to postoperative 2weeks, 3months, 6months). 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 17 Mar 2021.