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:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-24 @ 7:12 PM
NCT ID:
NCT02956603
Eligibility Criteria:
Inclusion criteria:
* For the prosthetic control graft arm:
* Must have previously undergone upper limb amputation
* Must be otherwise healthy (e.g. no severe pain syndromes or untreated mental health disorders)
* Must be American Society of Anesthesiologists (ASA) Class I (low surgical risk)
* Must have sufficient soft tissue quality to support performance of the operative procedures
* Must have NOT previously received the partial muscle graft surgery
* For the neuroma graft arm:
* Must have previously undergone upper limb amputation
* Must be otherwise healthy (e.g. no severe pain syndromes or untreated mental health disorders)
* Must have previously received the partial muscle graft surgery
* For the able-bodied arm:
* Must have NOT undergone upper limb amputation
* Must be in good health
Exclusion criteria:
* For the prosthetic control graft arm:
* Participants sustaining severe crushing or avulsion injuries with substantial superficial and deep scarring, may not be appropriate candidates for inclusion in the study
* For the able-bodied arm:
* Participants with a history of nerve pain may not be appropriate candidates for inclusion in the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02956603
Study Brief:
Protocol Section:
NCT02956603