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 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT04066894
Eligibility Criteria:
Inclusion Criteria:
* Cohort 1: Patients with pathologically proven diagnosis of primary rectal cancer
* Cohort 1: Patients who have previously undergone surgical resection and anastomosis (restorative) with curative intent treatment with or without chemoradiation
* Cohort 1: Patients treated with restorative surgical resection without radiation
* Cohort 1: Patients with any T-stage or N-stage rectal cancer that underwent treatment with radiation and restorative surgery
* Cohort 1: Patients with self-reported FI or LARS
* Cohort 1: Patients must be at least 18 years old and be able to speak and understand English
* Cohort 1: Patients must be willing to and able to sign an approved informed consent document
* Cohort 1: Patients must be \>= 24 months post-resection of rectal cancer
* Cohort 1: Patients must have failed prior conservative measures such as Metamucil and motility medications and already been assessed and treated in a pelvic floor rehabilitation program (biofeedback) designed to treat FI and LARS, and continue to experience significant defecatory dysfunction, allowable per principal investigator (PI) discretion
* Cohort 1: Patients must be willing and able to complete Patient Reported Outcomes Questionnaires for before device placement, during the testing phase following lead placement, and after implantation of the battery
* Cohort 1: Patients must be willing and able to undergo elective ARM testing to objectively measure pelvic floor function
* Cohort 1: Patients who have an average resting tone \< 40 mmHg (normal \> 40 mmHg) and maximal tolerance \< 200 milliliters (normal 200-300 milliliters) as measured by ARM
* Cohort 2: Patients with pathologically proven malignancy of the pelvis, other than rectal cancer (e.g. prostate, bladder, anus, vagina, vulva, cervix, uterus, or ovary)
* Cohort 2: Patients treated with standard of care radiation therapies without surgical resection
* Cohort 2: Patients with self-reported FI or other defecatory dysfunction
* Cohort 2: Patients must be at least 18 years old and be able to speak and understand English
* Cohort 2: Patients must be willing to and able to sign an approved informed consent document
* Cohort 2: Patients must be \>= 18 months post-pelvic chemoradiation
* Cohort 2: Patients must have already been assessed and treated in a pelvic floor rehabilitation program design to treat FI or other defecatory dysfunction and continue to experience significant defecatory dysfunction
* Cohort 2: Patients must be willing and able to complete Patient Reported Outcomes (PROs) and bowel and bladder diaries (Medtronic) at multiple times during the study
* Cohort 2: Patients must be willing and able to undergo elective ARM testing to measure pelvic floor function
* Cohort 2: Patients who have an average resting tone \< 40 mmHg (normal \> 40 mmHg) and maximal tolerance \< 200 milliliters (normal 200-300 milliliters) as measured by ARM
Exclusion Criteria:
* Cohort 1: Patients with co-morbid illnesses or concurrent disease, which in the judgment of the clinician obtaining informed consent, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
* Cohort 1: Any diverting bowel ostomy at the time of consent to this study
* Cohort 1: Patients with an absolute neutrophil count (ANC) \< 1.7 within 30 days of consent
* Cohort 1: Patients with an international normalized rate (INR) \> 1.3 within 30 days of consent
* Cohort 1: Patients with a platelet count \< 50 K within 30 days of consent
* Cohort 1: Patients currently being treated with chemotherapy or within preceding 30 days at the time consent
* Cohort 1: Patients previously treated with a SNS for urinary or FI
* Cohort 1: Patients who were documented to have an anastomotic leak following their restorative surgical resection
* Cohort 1: Patients with an Eastern Cooperative Oncology Group (ECOG) performance status \> 2 at the time of consent
* Cohort 1: Patients with an active infection requiring systemic therapy at the time of consent
* Cohort 1: Patients with a significant history of uncontrolled cardiac disease including, but not limited to hypertension, unstable angina, myocardial infarction within the last 4 months, and uncontrolled congestive heart failure
* Cohort 2: Co-morbid illnesses or other concurrent disease, which in the judgment of the clinician obtaining informed consent, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
* Cohort 2: Patients with an ANC \< 1.7 within 30 days of consent
* Cohort 2: Patients with an INR \> 1.3 within 30 days of consent
* Cohort 2: Patients with a platelet count \< 50 K, within 30 days of consent
* Cohort 2: Patients currently being treated with chemotherapy or within the preceding 30 days at the time of consent
* Cohort 2: Patients previously treated with a sacral nerve stimulator for urinary or fecal incontinence
* Cohort 2: Patients with an ECOG performance status \> 2 at the time of consent
* Cohort 2: Patients with an active infection requiring systemic therapy at the time of consent
* Cohort 2: Patients with a significant history of uncontrolled cardiac disease including, but not limited to hypertension, unstable angina, myocardial infarction within the last 4 months, and uncontrolled congestive heart failure
* Cohort 2: Patients with an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjogren's syndrome will not be excluded from the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04066894
Study Brief:
Protocol Section:
NCT04066894