RECRUITING

Ease of Use Study of the FemPulse System

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The objective of the study is to demonstrate that the FemPulse System can be used as indicated

Official Title

Ease of Use Study of the FemPulse System

Quick Facts

Study Start:2025-02-11

Study Completion:2025-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06885099

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Females, defined as a person with a cervix, ≥21 years old, with OAB symptoms, as confirmed by a physician. OAB is defined by urinary urgency, usually with urinary frequency and nocturia, with or without urgency urinary incontinence with symptoms . 2. Able to read, comprehend, and reliably provide informed consent and study-related information. 3. Willing and able to comply with study required procedures and visits	1. Any significant pain, neurologic, psychological condition or other factors, that in the investigator's judgment, might confound the protocol study assessments, and adherence to the protocol. 2. Has a metal pelvic implant or an active implantable medical device, including but not limited to a cardiac pacemaker, cardioverter-defibrillator or neurostimulator 3 History of a cardiac condition including, but not limited to, clinically significant abnormal ECG or arrhythmia that may interfere with study participation as determined by investigator. 4. Systemic condition or disease that may interfere with study participation or not an appropriate study candidate, as determined by study investigator.

Inclusion Criteria

Exclusion Criteria

1. Females, defined as a person with a cervix, ≥21 years old, with OAB symptoms, as confirmed by a physician. OAB is defined by urinary urgency, usually with urinary frequency and nocturia, with or without urgency urinary incontinence with symptoms .
2. Able to read, comprehend, and reliably provide informed consent and study-related information.
3. Willing and able to comply with study required procedures and visits

1. Any significant pain, neurologic, psychological condition or other factors, that in the investigator's judgment, might confound the protocol study assessments, and adherence to the protocol.
2. Has a metal pelvic implant or an active implantable medical device, including but not limited to a cardiac pacemaker, cardioverter-defibrillator or neurostimulator 3 History of a cardiac condition including, but not limited to, clinically significant abnormal ECG or arrhythmia that may interfere with study participation as determined by investigator.
4. Systemic condition or disease that may interfere with study participation or not an appropriate study candidate, as determined by study investigator.

Contacts and Locations

Study Contact

Roshini Study Director

CONTACT

469-766-9888

rjain@fempulse.com

Peter Fredericks

CONTACT

pfredericks@fempulse.com

Principal Investigator

Roshini Jain

STUDY_DIRECTOR

FemPulse Corporation

Study Locations (Sites)

Holy Cross Women's Hospital

Fort Lauderdale, Florida, 33334

United States

Collaborators and Investigators

Sponsor: FemPulse Corporation

Roshini Jain, STUDY_DIRECTOR, FemPulse Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-11

Study Completion Date2025-08-31

Study Record Updates

Study Start Date2025-02-11

Study Completion Date2025-08-31

Terms related to this study

Keywords Provided by Researchers

neuromodulation

Additional Relevant MeSH Terms

Overactive Bladder (OAB)