ClinicalTrials.gg
TerminatedNCT05082480Updated May 12, 2023

Evaluate the Effectiveness of Crosslinked HA on the Adhesion Preventing After Trigger Finger Release Surgery

An interventional study of Hyaluronic acid (HA) and Saline in Trigger Finger and Hyaluronic Acid, sponsored by SciVision Biotech Inc.. Terminated at 2 sites in Taiwan. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-05-12.

Sponsored by SciVision Biotech Inc. · Not applicable, Interventional, and Prevention

Why this study was terminated
poor enrollment
Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
All
01

Study summary

To Evaluate the Effectiveness of the use of a Novel Crosslinking Hyaluronan Hydrogel on the Prevention of the Adhesion Occurrence After Trigger Finger Release Surgery

Read the detailed description

The medical device is a bioabsorbable, extensible, crosslinked, 6% hyaluronic acid gel using fermentation sourced hyaluronic acid as a major component. This product could perfectly attach to the tissue surface, creating anti-adhesion layer which avoids post-surgical adhesion and is completely resorbed over time. This study is aimed to evaluate the effectiveness of the use of a novel crosslinking hyaluronan hydrogel on the prevention of the adhesion occurrence after trigger finger release surgery.

02

Conditions studied

  • Trigger Finger
  • Hyaluronic Acid
03

In context

Trigger Finger Disorder

93 studies on the registry are indexed under Trigger Finger Disorder; 22 are open to participants now.

This study's enrollment of 5 is below the median of 66 across 75 interventional studies indexed under Trigger Finger Disorder.

Browse Trigger Finger Disorder studies →

Lead sponsor

SciVision Biotech Inc. is the lead sponsor of 12 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Agree to participate in this study and sign form
  2. Age 20 to 65 years of male or female
  3. The trigger finger, except thumb, classified as 3 to 4 points and plan to conduct trigger finger release surgery;
  4. The trigger finger, except thumb, classified as 2 points with the symptom of flexion contracture and plan to conduct trigger finger release surgery;
  5. Agree to comply with the follow-up schedule of this study

Exclusion criteria

Exclusion Criteria:

  1. Target finger has other adhesion in tendon, joint, or proximal nerve, neuropathy, compression injury or other disease;
  2. Other fingers in the same hand as the target finger have other adhesion in tendon, joint, or proximal nerve, neuropathy, or compression injury;
  3. Contralateral finger has other adhesion in tendon, joint, or proximal nerve, neuropathy, or compression injury;
  4. The operation site was conducted tendon transplantation or any surgery in past 6 months;
  5. Receiving orthopedic-related treatment which may affect the evaluation of the study;
  6. The skin of the operation site with infection, deficiency, or needing skin transplantation;
  7. With poorly controlled chronic diseases, such as diabetes mellitus;
  8. Patient with disease (such as rheumatoid arthritis), malignant tumors, coagulation diseases, heart diseases, mental diseases, etc., may cause patients to participate in the trial at higher risk;
  9. Patient who has taken cortisol within the past 6 months, systemic within the past 2 months, drugs within past 3 months, or non-steroidal anti-inflammatory drugs (NSAIDs) everyday within 1 week or NSAIDs within 8 hours occasionally. (subjects who have received inhaled/intranasal corticosteroids could be considered to include.);
  10. With clinical meaningful coagulation disorders, underdoing anticoagulant treatment or taking blood circulation promotion and blood stasis removement medications within the past 10 days;
  11. With history of or allergy to hyaluronic acid or any component of the device; With history of hypersensitivity or allergy to Gram-positive bacteria or Streptococcus proteins; other severe hypersensitivity history unsuitable for participating in the study;
  12. Pregnant, planning pregnancy or in breastfeeding females;
  13. Other circumstances which judged to be unsuitable for participating in the study by the investigator.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
5 participants (actual)

Study arms

  • Experimental
    Hyaluronic acid (HA)

    Hyaluronic acid (HA)

    Device: Hyaluronic acid (HA)

  • Placebo comparator
    Saline

    Saline

    Device: Saline

Interventions

  • DeviceHyaluronic acid (HA)

    Hyaluronic acid (HA)

  • DeviceSaline

    Saline

06

What researchers measure

Primary outcomes

  1. The percentage of Total Active Motion (TAM) score for target finger.

    The percentage of Total Active Motion (TAM) score for target finger at 30 days post-operation.

    Time frame: 30 days post-operation

Secondary outcomes

  1. The percentage of TAM score of target finger.

    The percentage of TAM score of target finger at baseline, 14, 60, 90, and 180 days post-operation.

    Time frame: baseline, 14, 60, 90, and 180 days post-operation

  2. TAM score of target finger.

    TAM score of target finger at baseline, 14, 30, 60, 90, and 180 days post-operation.

    Time frame: baseline, 14, 30, 60, 90, and 180 days post-operation

  3. The grade of TAM score of target finger and contralateral finger.

    The grade of TAM score of target finger and contralateral finger at baseline, 14, 30, 60, 90, and 180 days post-operation

    Time frame: baseline, 14, 30, 60, 90, and 180 days post-operation

  4. Subjects self-evaluating Visual Analogue Scale (VAS) in pain of target finger at baseline, 14, 30, 60, 90, and 180 days post-operation.

    Subjects self-evaluating Visual Analogue Scale (VAS) in pain of target finger at baseline, 14, 30, 60, 90, and 180 days post-operation. The VAS scale uses a 100 mm line labelled at '0' with 'no pain' and '100' with 'worst pain'

    Time frame: baseline, 14, 30, 60, 90, and 180 days post-operation

  5. Subjects self-evaluating Quick Disabilities of the Arm, Shoulder and Hand Score (Quick-Dash).

    Subjects self-evaluating Quick Disabilities of the Arm, Shoulder and Hand Score (Quick-Dash) at baseline, 14, 30, 60, 90, and 180 days post-operation.

    Time frame: baseline, 14, 30, 60, 90, and 180 days post-operation

  6. The evaluation of tendon by sonography.

    The evaluation of tendon by sonography at baseline, 14, 30, 60, 90, and 180 days post-operation.

    Time frame: baseline, 14, 30, 60, 90, and 180 days post-operation

  7. Subjects self-evaluating Visual Analogue Scale (VAS) in satisfaction

    Subjects self-evaluating satisfaction at 14, 30, 60, 90, and 180 days post-operation. Patients rate their treatment satisfaction based on a 100 mm VAS. The VAS scale uses a 100 mm line labelled at '0' with 'least satisfaction' and '100' with 'highest satisfaction'.

    Time frame: 14, 30, 60, 90, and 180 days post-operation

  8. The incidence, severity and correlation of adverse event (AE) and serious adverse event (SAE).

    The incidence, severity and correlation of adverse event (AE) and serious adverse event (SAE).

    Time frame: baseline, 14, 30, 60, 90, and 180 days post-operation

07

Study locations

2 sites
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
    Kaohsiung, Taiwan
  • Kaohsiung Municipal Ta-Tung Hospital
    Kaohsiung, Taiwan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05082480
Lead sponsor
SciVision Biotech Inc.
Responsible party
Sponsor
First posted
Oct 19, 2021
Start date
May 5, 2022
Primary completion
Apr 28, 2023
Completion
Apr 28, 2023
Last update
May 12, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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