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:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07391735
Eligibility Criteria:
Inclusion Criteria:
* Adults (18 years old and older).
* Ability to understand consent process and questionnaires. Patients with ready access to a smartphone, compatible smart device (operating system 5.0 version, also known as Lollipop, for Android and 13 or later version for iOS), smartphone aptitude, smartphone with sufficient memory space for the relevant app, and willingness to participate in the study as assessed by a questionnaire.
* Patients undergoing one of the following surgeries within the Brigham and Women's Pain Management Practice:
1. Spinal cord stimulator implantation
2. Spinal cord stimulator explant
3. Spinal cord stimulator revision
4. Intrathecal pump implantation
5. Intrathecal pump explant
6. Intrathecal pump revision
* Ability to attend all standard surgery follow-up appointments at Brigham and Women's Hospital.
* Ability to understand and sign written informed consent documents.
Exclusion Criteria:
* Cognitive or physical impairment that would prevent patient from entering data in MHP.
* Any acute or chronic condition that would limit the ability of the patient to participate in the study.
* Any patient who is experiencing an ongoing infection prior to undergoing a surgical revision/explant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07391735
Study Brief:
Protocol Section:
NCT07391735