AdhesionNCT05036525
Evaluation of the Efficacy and Safety of a Hyaluronic Acid Gel in Adhesion Prevention After Open Thyroidectomy.
A study testing HANBIO BarriGel in people with Adhesion and Thyroid Diseases, run by HAN Biomedical Inc at 5 sites in Taiwan.
Trial summary
The aim of this study is to assess the safety and efficacy of HANBIO BarriGel to prevent thyroidectomy postoperative adhesions Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Adhesion, Thyroid Diseases
- What is being tested?
- HANBIO BarriGel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 5 sitesTaiwan
- Study dates
- 17 Jun 2022to 17 Apr 2023
- Phase
- Interventional
- 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
- Male and female between 20 and 70 years of age.
- Patients diagnosed with benign goiter or thyroid cancer that will undergo open thyroidectomy (either unilateral or bilateral total thyroidectomy with or without central lymph node dissection).
- Naïve patients to thyroid surgery.
- Subjects are willing to comply with all aspects of the study and have signed informed consent form.
Who cannot join
- Pregnant or lactating female patients.
- Presence of severe and uncontrolled illness such as stroke, hypertension, diabetes, chronic renal failure, coagulopathy, drug abuse.
- Patients with previous neck radiotherapy within 1 year.
- Concurrent diseases/conditions which will be unable to evaluate the outcomes.
- Patients receiving any adhesion prevention adjuvant.
- Previous history of Keloid or hypertrophic scar.
Show all 11Show fewer
- Anticoagulant used within a week from surgery.
- Subjects are hypersensitive to sodium hyaluronate.
- Participate in another clinical trial within 1 month.
- Patients presence of surgical site infection.
- Patients are with abnormal clinical test (appendix 1) result within one month or ECOG performance status (appendix 2) score ranged from 3-4.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Taiwan5 sites
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City
Kaohsiung Veterans General Hospital
Kaohsiung City
Keelung Chang Gung Memorial Hospital
Keelung
National Taiwan University Hospital
Taipei
Taipei Veterans General Hospital
Taipei
About this study
Official title: Evaluation of the Efficacy and Safety of a High Molecular Weight Native Hyaluronic Acid Gel (HANBIO BarriGel) in Adhesion Prevention After Open Thyroidectomy: a Prospective, Randomized Controlled, Single Blind Study.
The aim of this study is to assess the safety and efficacy of HANBIO BarriGel to prevent thyroidectomy postoperative adhesions
Read the detailed description
The objective of this study is to evaluate the efficacy of HANBIO BarriGel in the prevention of postoperative adhesion for patients who will undergo open thyroidectomy. The dysphagia and adhesion severity will be assessed at specific visits pre and/or post-operation for both treatment group and control group. The post-operative condition, and the adverse event information will be collected for evaluation of tolerability and safety of the product.
- Conditions
- Adhesion, Thyroid Diseases
- Being tested
- HANBIO BarriGel
- Medical subject headings
- Tissue Adhesions, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HANBIO BarriGelDevice
an anti-adhesive product
| Study group | Role | What they receive |
|---|---|---|
| use HANBIO BarriGel | Experimental | Not described Receives: Device: HANBIO BarriGel |
| No anti-adhesive product | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dysphagia Handicap Index (DHI)
Measured: Preoperative 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start17 Jun 2022
- Primary completion17 Apr 2023
- Study completion17 Apr 2023
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.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- HAN Biomedical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05036525
- Sponsor's protocol ID
- HAN2013001-CT02
- Status last verified
- Mar 2024
- First submitted
- 2 Sep 2021
- Last updated
- 5 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of a High Molecular Weight Native Hyaluronic Acid Gel (HANBIO BarriGel) in Adhesion Prevention After Open Thyroidectomy: a Prospective, Randomized Controlled, Single Blind Study.
- ClinicalTrials.gov ID
- NCT05036525
- Acronym / sponsor ID
- HAN2013001-CT02
- Conditions
- Adhesion, Thyroid Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- HAN Biomedical IncIndustry (pharma, biotech, devices)
- Study start
- 17 Jun 2022 (actual)
- Primary completion
- 17 Apr 2023 (actual)
- Study completion
- 17 Apr 2023 (actual)
- First posted
- 5 Sep 2021 (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.
The aim of this study is to assess the safety and efficacy of HANBIO BarriGel to prevent thyroidectomy postoperative adhesions
Detailed description
The objective of this study is to evaluate the efficacy of HANBIO BarriGel in the prevention of postoperative adhesion for patients who will undergo open thyroidectomy. The dysphagia and adhesion severity will be assessed at specific visits pre and/or post-operation for both treatment group and control group. The post-operative condition, and the adverse event information will be collected for evaluation of tolerability and safety of the product.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| use HANBIO BarriGel | Experimental | Device: HANBIO BarriGel |
| No anti-adhesive product | No intervention | – |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female between 20 and 70 years of age.
- Patients diagnosed with benign goiter or thyroid cancer that will undergo open thyroidectomy (either unilateral or bilateral total thyroidectomy with or without central lymph node dissection).
- Naïve patients to thyroid surgery.
- Subjects are willing to comply with all aspects of the study and have signed informed consent form.
Key exclusion criteria (11 listed)
- Pregnant or lactating female patients.
- Presence of severe and uncontrolled illness such as stroke, hypertension, diabetes, chronic renal failure, coagulopathy, drug abuse.
- Patients with previous neck radiotherapy within 1 year.
- Concurrent diseases/conditions which will be unable to evaluate the outcomes.
- Patients receiving any adhesion prevention adjuvant.
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 |
|---|---|---|
| HANBIO BarriGelan anti-adhesive product | Device | use HANBIO BarriGel |
Primary outcome
Dysphagia Handicap Index (DHI)
Time frame: Preoperative 6 weeks
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 5 Mar 2024.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HANBIO BarriGel in people with Adhesion and Thyroid Diseases, run by HAN Biomedical Inc at 5 sites in Taiwan.
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: finished, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Taiwan. 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.
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?
Dysphagia Handicap Index (DHI) (time frame: Preoperative 6 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 5 Mar 2024.