TerminatedNot Applicable

Post Approval Study to Evaluate the Safety and Performance of GENTA-FOIL Resorb® in Hand Surgery

Stopped: slow recruitment.

Greece, United Kingdom15 participantsStarted 2024-10-14

Plain-language summary

Single arm study to evaluate the safety and performance of Genta-Foil resorb® for the prevention of tissue adhesions

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Subject is male or female, ≥18 years of age;
✓. Subject is willing and able to give written informed consent;
✓. Subject is scheduled for one if the following surgical procedures:
✓. Subject is willing and able to comply with the study procedures during surgery and the post-surgical follow up period.

✕. Subject is known to be sensitive to any of the device components e.g. Gentamicin (aminoglycosides) or equine collagen.
✕. Subject is known to be non-compliant with medical treatment.
✕. Subject has any known impaired renal function/autoimmune illness/neuromuscular disease (such as Parkinson's or Myasthenia Gravis).
✕. Subject is currently taking an Aminoglycoside antibiotic as stand-alone treatment or in combination with other antibiotics
✕. Subject is pregnant or actively breastfeeding.
✕. Subject has active infection at surgical site
✕. 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.
✕. Subject is currently enrolled in another clinical study that would interfere with their ability to participate in this study

Restoration of hand mobility

Timeframe: At 90 days post-surgery

NCT IDNCT04482140

SponsorAdvanced Medical Solutions Ltd.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-11-07

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Subject is male or female, ≥18 years of age;
✓. Subject is willing and able to give written informed consent;
✓. Subject is scheduled for one if the following surgical procedures:
✓. Subject is willing and able to comply with the study procedures during surgery and the post-surgical follow up period.

✕. Subject is known to be sensitive to any of the device components e.g. Gentamicin (aminoglycosides) or equine collagen.
✕. Subject is known to be non-compliant with medical treatment.
✕. Subject has any known impaired renal function/autoimmune illness/neuromuscular disease (such as Parkinson's or Myasthenia Gravis).
✕. Subject is currently taking an Aminoglycoside antibiotic as stand-alone treatment or in combination with other antibiotics
✕. Subject is pregnant or actively breastfeeding.
✕. Subject has active infection at surgical site
✕. 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.
✕. Subject is currently enrolled in another clinical study that would interfere with their ability to participate in this study