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 @ 4:44 PM
Ignite Modification Date:
2025-12-24 @ 4:44 PM
NCT ID:
NCT03083366
Eligibility Criteria:
Inclusion Criteria:
* Age \> 18 years
* Ability to implant device less than 12 weeks post-spinal cord injury (SCI)
* Presence of acute SCI at or above T12
* American Spinal Injury Association (ASIA) Scale A or B
* Expectation to perform clean intermittent catheterization (CIC) personally or have caretaker perform CIC
Exclusion Criteria:
* Inability to perform CIC
* Pre-existing SCI
* Pre-existing progressive neurological disorder
* Autonomic dysreflexia
* Prior sacral back surgery
* Posterior pelvic fracture with distortion of the sacroiliac joint
* Prior urethral sphincter or bladder dysfunction
* Chronic urinary tract infections prior to SCI
* Pregnancy at the time of enrollment
* Presence of coagulation disorder or need for anticoagulation that they cannot be stopped temporarily for procedure
* Any significant co-morbidity or illness that would preclude their participation or increase the risk to them having a surgical procedure
* Active untreated infection
* Traumatic injury to the genitourinary system
* Prior pelvic radiation, bladder cancer or other surgical procedure to the bladder that would effect baseline bladder physiology
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03083366
Study Brief:
Protocol Section:
NCT03083366