RECRUITING

Usability 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 in the Instructions for Use (IFU), as applicable.

Official Title

Usability Study of the FemPulse System

Quick Facts

Study Start:2024-07-18

Study Completion:2024-12-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06347380

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
* Females, defined as a person with a uterus and cervix, ≥21 years old, with a diagnosis of OAB and symptoms for more than 6 months, as confirmed by a physician * Able to read, comprehend, and reliably provide informed consent and study-related information. * Willing and able to comply with study required procedures and visits (e.g., maintaining consistent medication use, fluid intake, diary completion). * Has adequate cognitive and manual capabilities to operate the FemPulse System and other components (e.g., mobile app) as assessed by the investigator.	* Currently pregnant, was pregnant in the past 12 months or intending to conceive during the study period. * Plans to begin other OAB therapies or otherwise change their existing therapy regimen during the study period. * Not an appropriate study candidate as determined by investigator.

Inclusion Criteria

Exclusion Criteria

* Females, defined as a person with a uterus and cervix, ≥21 years old, with a diagnosis of OAB and symptoms for more than 6 months, as confirmed by a physician
* Able to read, comprehend, and reliably provide informed consent and study-related information.
* Willing and able to comply with study required procedures and visits (e.g., maintaining consistent medication use, fluid intake, diary completion).
* Has adequate cognitive and manual capabilities to operate the FemPulse System and other components (e.g., mobile app) as assessed by the investigator.

* Currently pregnant, was pregnant in the past 12 months or intending to conceive during the study period.
* Plans to begin other OAB therapies or otherwise change their existing therapy regimen during the study period.
* Not an appropriate study candidate as determined by investigator.

Contacts and Locations

Study Contact

Roshini Jain

CONTACT

4697669888

rjain@fempulse.com

Peter Fredericks

CONTACT

pfredericks@fempulse.com

Principal Investigator

Roshini Jain

STUDY_DIRECTOR

Sponsor GmbH

Study Locations (Sites)

Holy Cross Women's Hospital

Fort Lauderdale, Florida, 33334

United States

Univ. of Washington

Seattle, Washington, 98133

United States

Collaborators and Investigators

Sponsor: FemPulse Corporation

Roshini Jain, STUDY_DIRECTOR, Sponsor GmbH

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 Date2024-07-18

Study Completion Date2024-12-30

Study Record Updates

Study Start Date2024-07-18

Study Completion Date2024-12-30

Terms related to this study

Keywords Provided by Researchers

neuromodulation

Additional Relevant MeSH Terms

Overactive Bladder