Thyroid DiseasePhase 3NCT01696305
Study for Hyalobarrier to Evaluate Anti-adhesive Effect and Safety Compared to Guardix-SG After Thyroidectomy
A Phase 3 study testing Hyalobarrier and Guardix-SG in people with Thyroid Disease, run by Green Cross Corporation at 3 sites in South Korea.
Trial summary
This study is a randomized, double-blind, active controlled phase 3 trial in the patients with thyroid disease, who will undergo total thyroidectomy (excluding the patients with the patient with the past history of thyroid surgery). Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Thyroid Disease
- What is being tested?
- Hyalobarrier and Guardix-SG
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Dec 2012to Feb 2014
- 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 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female between 18 and 79 years of age
- Patients diagnosed with thyroid disease who will undergo total thyroidectomy
- Naive patients to thyroid surgery
- Given written informed consent
- Childbearing potential female patients who give the consent for contraception during the study
Who cannot join
- Pregnant or breast-feeding female patients
- Abnormal coagulation panel test
- Clinically abnormal laboratory values
- Inappropriate general health conditions
- Past or current medication history for hyperthyroidism
- Medication with aspirin (or anti-platelet) before surgery
Show all 10Show fewer
- Current medication with anticoagulants
- Inoperable (thyroidectomy) concurrent diseases
- Concurrent diseases/conditions which will be unable to evaluate the primary and secondary outcomes
- Participating in other interventional clinical trial
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Konkuk University Medical Center
Seoul
Korea University Anam Hospital
Seoul
Korea University Guro Hospital
Seoul
About this study
Official title: Prospective, Randomized, Double Blind, Multicenter Study for Hyalobarrier ® to Evaluate Anti-adhesive Effect and Safety Compared to Guardix-SG® After Thyroidectomy
This study is a randomized, double-blind, active controlled phase 3 trial in the patients with thyroid disease, who will undergo total thyroidectomy (excluding the patients with the patient with the past history of thyroid surgery).
An eligible patient will be randomized and allocated to either the test group (Hyalobarrier) or active-comparator group (Guardix-SG). He/she will undergo marshmallow esophagography in detecting esophageal dysmotility at 6 weeks after study intervention and will be followed for 12weeks.
Read more
During the study, both the patients and the observer for the primary and secondary efficacy evaluation will be masked.
Non-inferiority of the test device (Hyalobarrier) compared to the reference device (Guardix-SG) will be confirmed using the primary efficacy outcome,the percentage of normal esophageal transit.
- Conditions
- Thyroid Disease
- Being tested
- Hyalobarrier, Guardix-SG
- Keywords
- Thyroid disease, Hyalobarrier, Thyroidectomy, anti-adhesive effect
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyalobarrierDevice
Guardix-SGDevice
| Study group | Role | What they receive |
|---|---|---|
| Hyalobarrier | Experimental | ACP200 (Auto-crosslinked polysaccharide:inner ester of hyaluronic acid) 30mg/ml*10ml/syringe and 5cm-cannula Receives: Device: Hyalobarrier |
| Guardix-SG | Active comparator | Poloxamer/sodium alginate mixture 6g/syringe Receives: Device: Guardix-SG |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of normal esophageal transit in marshmallow esophagography
Measured: 6 Weeks after intervention
Secondary outcomes (7)
Adhesion severity using VAS
Measured: Baseline and 1, 6 and 12 weeks
Swallow impairment
Measured: Baseline and 1, 6 and 12 weeks
Voice impairment
Measured: Baseline and 1, 6 and 12 weeks
voice behavior using Voice Range Profile (VRP) assessment
Measured: Baseline and 1, 6 and 12 weeks
Injury of recurrent laryngeal nerve
Measured: Baseline and 1, 6 and 12 weeks
Postoperative Sore Throat within 24hours after thyroidectomy
Measured: Pre- and Post (0, 24h)-opreation
Adverse Events
Measured: during 12 weeks after investigational device use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2012 (estimated)
- Study startDec 2012
- Primary completionJan 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Green Cross Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hoon Yub Kim, M.D., Ph.D., Principal investigator, Korea University Anam HospitalJae-Bok Lee, M.D., Ph.D., Principal investigator, Korea University Guro HospitalKyoung Sik Park, M.D., Ph.D., Principal investigator, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01696305
- Sponsor's protocol ID
- Hyalobarrier_P3
- Status last verified
- Feb 2014
- First submitted
- 26 Sep 2012
- Last updated
- 28 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Double Blind, Multicenter Study for Hyalobarrier ® to Evaluate Anti-adhesive Effect and Safety Compared to Guardix-SG® After Thyroidectomy
- ClinicalTrials.gov ID
- NCT01696305
- Acronym / sponsor ID
- Hyalobarrier_P3
- Conditions
- Thyroid Disease
- Keywords
- Thyroid disease, Hyalobarrier, Thyroidectomy, anti-adhesive effect
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Green Cross CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 1 Oct 2012 (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.
This study is a randomized, double-blind, active controlled phase 3 trial in the patients with thyroid disease, who will undergo total thyroidectomy (excluding the patients with the patient with the past history of thyroid surgery).
An eligible patient will be randomized and allocated to either the test group (Hyalobarrier) or active-comparator group (Guardix-SG). He/she will undergo marshmallow esophagography in detecting esophageal dysmotility at 6 weeks after study intervention and will be followed for 12weeks.
During the study, both the patients and the observer for the primary and secondary efficacy evaluation will be masked.
Non-inferiority of the test device (Hyalobarrier) compared to the reference device (Guardix-SG) will be confirmed using the primary efficacy outcome,the percentage of normal esophageal transit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyalobarrier | Experimental | Device: HyalobarrierACP200 (Auto-crosslinked polysaccharide:inner ester of hyaluronic acid) 30mg/ml*10ml/syringe and 5cm-cannula |
| Guardix-SG | Active comparator | Device: Guardix-SGPoloxamer/sodium alginate mixture 6g/syringe |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female between 18 and 79 years of age
- Patients diagnosed with thyroid disease who will undergo total thyroidectomy
- Naive patients to thyroid surgery
- Given written informed consent
- Childbearing potential female patients who give the consent for contraception during the study
Key exclusion criteria (10 listed)
- Pregnant or breast-feeding female patients
- Abnormal coagulation panel test
- Clinically abnormal laboratory values
- Inappropriate general health conditions
- Past or current medication history for hyperthyroidism
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 |
|---|---|---|
| Hyalobarrier | Device | Hyalobarrier |
| Guardix-SG | Device | Guardix-SG |
Primary outcome
The percentage of normal esophageal transit in marshmallow esophagography
Time frame: 6 Weeks after intervention
7 secondary outcomes
Adhesion severity using VAS
Time frame: Baseline and 1, 6 and 12 weeks
Swallow impairment
Time frame: Baseline and 1, 6 and 12 weeks
Voice impairment
Time frame: Baseline and 1, 6 and 12 weeks
voice behavior using Voice Range Profile (VRP) assessment
Time frame: Baseline and 1, 6 and 12 weeks
Injury of recurrent laryngeal nerve
Time frame: Baseline and 1, 6 and 12 weeks
Postoperative Sore Throat within 24hours after thyroidectomy
Time frame: Pre- and Post (0, 24h)-opreation
Adverse Events
Time frame: during 12 weeks after investigational device use
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 28 Feb 2014.
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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.
Hoon Yub Kim, M.D., Ph.D. principal investigator
Korea University Anam Hospital
Jae-Bok Lee, M.D., Ph.D. principal investigator
Korea University Guro Hospital
Kyoung Sik Park, M.D., Ph.D. principal investigator
Konkuk University Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hyalobarrier and Guardix-SG in people with Thyroid Disease, run by Green Cross Corporation at 3 sites 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 5 inclusion and 10 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 28 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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?
The percentage of normal esophageal transit in marshmallow esophagography (time frame: 6 Weeks after intervention). 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 28 Feb 2014.