Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT01014494
Eligibility Criteria:
Inclusion Criteria:
\- Subjects aged 18 years and above with complete division of the Flexor Digitorum Profundus (FDP) tendon in Zone II.
Exclusion Criteria:
* Subjects with additional complicated injuries
* Subjects whose flexor tendon repair involves a finger with less than full tendon function prior to the injury requiring repair
* Subjects who are undergoing surgical repair of the severed tendon(s) more than four days after the injury occurred.
* Subjects with a history of clinical significant hypersensitivity to any of the devices, drugs or surgical dressings to be used in this trial.
* Subjects with conditions which may delay healing.
* Subjects who are taking, or have taken, any investigational drugs within 3 months prior to the screening visit.
* Females who are pregnant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01014494
Study Brief:
Protocol Section:
NCT01014494