Post Approval Study to Evaluate the Safety and Performance of GENTA-FOIL Resorb® in Hand Surgery (NCT04482140) | Clinical Trial Compass
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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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