Gynecology: Clinical Studies Open For Enrollment
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Eligibility
- Adult female at least18 years of age who has primary symptoms of FI for at least 12 months as confirmed by medical history and presents with ≥4 uncontrolled passages of solid or liquid stool as recorded in a 14-Day Diary at Screening.
- Has a history of obstetric anal sphincter injury (e.g., episiotomy, perineal tear) as confirmed by participant’s medical records and/or endoanal ultrasound.
- Failed conservative treatment (e.g., dietary modification, antidiarrheal medications, pelvic floor muscle training, biofeedback) for at least 6 months prior to enrollment.
- Has a Cleveland Clinic Florida Incontinence Score (CCFIS) ≥9 at Baseline.
- For the duration of study participation, must be willing and able to comply with the study procedures, be mentally competent and able to understand all study requirements, and must agree to read and sign the informed consent form prior to any study-related procedures.
- Exclusion Criteria:
- Simultaneously participating in another investigational drug or device study or has completed the follow-up phase for the primary endpoint of any previous study less than 30 days prior to the first evaluation in this study.
- Is pregnant or planning to become pregnant within the next 2 years.
- Has an implanted stimulation neuromodulation system (sacral or tibial) and symptoms are unstable as determined by the physician.
- Has received injection of a bulking agent within 1-year prior to the first evaluation in the study.
- Has known rectal sensory dysfunction (e.g., hypersensitivity or hyposensitivity).
- Any cancer that has undergone treatment within the past 12 months.
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT05776277
Principal Investigator
Patrick Popiel, MD
Contact for Study Screening
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Eligibility
- At least 18 years of age
- Patients must have newly diagnosed, Stage II-IV low-grade serous ovarian cancer
- Patients must be able to take oral medications
- Patients may not have received previous hormonal therapy for the treatment of this disease
- Patients with NO central nervous system metastases
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT04095364
Principal Investigator
Tana Pradhan, MD
Contact for Study Screening
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Eligibility
- At least 18 years of age
- Diagnosis of endometrial cancer
- Measurable stage III, measurable stage IVA, stage IVB, or recurrent endometrial cancer
- Must have a measurable lesion on CT or MRI scan
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT03914612
Principal Investigator
Tana Pradhan, MD
Contact for Study Screening