Trials / Completed
CompletedNCT05036525
Evaluation of the Efficacy and Safety of a Hyaluronic Acid Gel in Adhesion Prevention After Open Thyroidectomy.
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.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- HAN Biomedical Inc · Industry
- Sex
- All
- Age
- 20 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | HANBIO BarriGel | an anti-adhesive product |
Timeline
- Start date
- 2022-06-17
- Primary completion
- 2023-04-17
- Completion
- 2023-04-17
- First posted
- 2021-09-05
- Last updated
- 2024-03-05
Locations
5 sites across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT05036525. Inclusion in this directory is not an endorsement.