Peristeen Light Explorative Clinical Investigation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorColoplast A/S
About this trial
The goal of this exploratory clinical investigation is to understand the clinical benefits of Peristeen Light in adult patients with faecal incontinence, chronic constipation and/or time-consuming bowel management procedures.
The primary objective is to evaluate changes in bowel-function when using Peristeen Light. Participants will use Peristeen Light for 12 weeks test period.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Has given written informed consent
Is at least 18 years old
Has full legal capacity
Is able (assessed by investigator) and willing to adhere to clinical investigational procedures during clinical investigation-al duration
Disqualifiers
Is participating in any other clinical investigation during this investigation
Has previously completed this investigation
Is former or current user of transanal irrigation (low- and high volume)
Has known hypersensitivity towards the device used in the investigation
Trial design
Design model
Single group
Treatments tested in this trial
Peristeen Light - trans anal irrigation system
DeviceSubjects naive to TAI will use Peristeen Light trans anal irrigation
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Exploratory single-arm interventional investigationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Bowel function measured on a 10 cm Visual Analog Scale (VAS) at Baseline Visit (V1) and End of Clinical Investigation Visit (V7).
0 cm = worst possible bowel function and 10 cm = best possible bowel function.
Time frame
From enrollment to the end of treatment at week 12.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov