BridgeMD
New treatment option for Faecal Incontinence
Official title Peristeen Light Explorative Clinical Investigation
ClinicalTrials.gov ID: NCT07126327
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
- Has access to and is able to use a smartphone
You likely can't join if
- 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
- Is pregnant
- Has known anal stenosis
See the full eligibility criteria
- 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
- Has access to and is able to use a smartphone
- Has constipation and/or faecal incontinence based on one or more of the following symptoms during the last 3 month: Straining in more than 25% of defecations, lumpy stools (Bristol Stool Type 1 and 2) in more than 25%...
- Is assessed (by investigator) to have a need for low-volume TAI minimum every other day
- 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
- Is pregnant
- Has known anal stenosis
- Has active/recurrent colorectal cancer
- Has had anastomotic colorectal surgery within the last 3 months
- Has ischaemic colitis
- Has active inflammatory bowel disease
- Has acute diverticulitis or diverticular abscess
- Has medicine induced constipation (e.g. due to opioids)
- Has chronic diarrhea
- Has bowel dysfunction due to neurogenic disorder(s)
- Is in need of high-volume TAI (as estimated by investigator)
The study team makes the final eligibility decision.
Where it's taking place
- Aarhus, Gotland, Denmark
- Bologna, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aarhus, Gotland, Denmark; Bologna, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.