A Clinical Investigation Evaluating Peristeen® Performance (CP342)
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|ClinicalTrials.gov Identifier: NCT05381610|
Recruitment Status : Recruiting
First Posted : May 19, 2022
Last Update Posted : July 7, 2022
|Condition or disease||Intervention/treatment||Phase|
|Neurogenic Bowel||Device: Peristeen||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Open Label|
|Official Title:||A Clinical Investigation Evaluating Peristeen® Performance Characteristics of Scintigraphic Measurements in Patients With Neurogenic Bowel Dysfunction|
|Actual Study Start Date :||June 1, 2022|
|Estimated Primary Completion Date :||April 1, 2023|
|Estimated Study Completion Date :||August 1, 2023|
Experimental: Neurogenic Bowel
This is a US-Only, early feasibility, Investigational Device Exemption - Non-Significant Risk (IDE-NSR), single-center, open label study evaluating the effects of Peristeen, compared to a LVE administered into the rectum. The subjects to be analysed will be subjects with : Neurogenic Bowel Dysfunction (NBD). The NBD cohort will be broken down into two phases: LVE and Peristeen. See Statistical section 10 for more infor-mation on cohort and sub-group analyses.
The Peristeen system will be handled by Coloplast trained personnel. The investigator and a trained nurse will participate in all the investigation related procedures. The nurse is trained in the handling of the investi-gational product as well as this is described in detail in the Instruction for Use (IFU). Subjects (and their caregivers, if appropriate) will also be trained on the use of Peristeen prior to independent use at home.
- The differences in the scintigraphy images, i.e. percentage of fecal matter, will be compared between the LVE and Peristeen. [ Time Frame: 72 days ]The subject's fecal matter movement will be measured radiologically and the percent changes in both a large-volume enema and Peristeen treatment will be measured.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05381610
|Contact: Carri Brownefirstname.lastname@example.org|
|United States, North Carolina|
|Charlotte, North Carolina, United States, 28204|
|Contact: Jessica Kearney-Bryan, RN 704-355-0244 mailto:Jessica.email@example.com|