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Hand surgery foil study halted early – only 15 patients enrolled

NCT ID NCT04482140

Prevention Sponsor: Advanced Medical Solutions Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a foil called GENTA-FOIL resorb® placed during hand surgery to prevent sticky scar tissue (adhesions) that can limit movement. It included 15 adults having tendon repair or bone fracture surgery. The study was terminated early, so results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

15 people

The number who actually took part.

Started

Oct 2024

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adult patients who are undergoing hand surgery with the Genta-Foil resorb® device, and who meet all inclusion criteria and none of the exclusion criteria

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subject is male or female, ≥18 years of age; 2. Subject is willing and able to give written informed consent; 3. Subject is scheduled for one if the following surgical procedures: * 3a. extensor tendon repair zones I to VI. * 3b. flexor tendon repair zones I to VI. * 3c. open reduction and internal fixation to repair hand fractures of proximal phalanx, and/or middle phalanx, and/or metacarpals 4. Subject is willing and able to comply with the study procedures during surgery and the post-surgical follow up period. Exclusion Criteria: 1. Subject is known to be sensitive to any of the device components e.g. Gentamicin (aminoglycosides) or equine collagen. 2. Subject is known to be non-compliant with medical treatment. 3. Subject has any known impaired renal function/autoimmune illness/neuromuscular disease (such as Parkinson's or Myasthenia Gravis). 4. Subject is currently taking an Aminoglycoside antibiotic as stand-alone treatment or in combination with other antibiotics 5. Subject is pregnant or actively breastfeeding. 6. Subject has active infection at surgical site 7. Subject has any significant or unstable medical or psychiatric condition that, in the opinion of the Investigator, would interfere with their ability to participate in the study, or affect the study outcomes. 8. Subject is currently enrolled in another clinical study that would interfere with their ability to participate in this study

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Conditions

The condition(s) this trial relates to.

Tissue Adhesions

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Tissue adhesions, surgery-induced

Contacts and locations

Locations

  • KAT Attica General Hospital

    Athens, Athens, 14561, Greece

  • Royal Victoria Infirmary Newcastle Upon Tyne NHS Foundation Trust

    Newcastle upon Tyne, Tyne and Wear, NE1 4LP, United Kingdom

  • Whiston Hospital - Mersey and West Lancashire Teaching Hospitals Trust

    Rainhill, Merseyside, L35 5DR, United Kingdom