Pilot Study Evaluating the Use of a New Device for Transanal Irrigation in Patient With Bowel Disorders

The study descripted of efficacy of IryPump®R Set in term of success of the procedure at each irrigation

Study Overview

• Status: Completed
• Conditions: Therapeutic Irrigation
• Intervention / Treatment: Device: IryPump R Set

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patient is at least 18 years old,
2. Patient having signed an informed consent
3. Patient having neurologic or non neurologic bowel disorders, being initiated to TAI and practicing TAI with Peristeen® for the management of her/his bowel disorders, for at least 6 weeks, with satisfying results.
4. Patient practicing TAI on the basis of 1 procedure/ week as a minimum or more frequently
5. Patient capable to perform the procedure of transanal irrigation himself or with the help of a caregiver
6. Patient having a mental capacity to participate to the study (i.e. to understand the study and to answer to the questions)
7. Patient agrees to test IryPump® Set R for a time corresponding to 5 consecutive irrigations and a maximum of 4 weeks.
8. Patient covered by social security

Exclusion Criteria:

1. Patient with bowel obstruction
2. Patient already participating in another clinical study or who have previously participated in this investigation,
3. Pregnant or breast-feeding woman

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: IryPump R Set; A new set for transanal irrigation composed by 2 parts : 1 pump and 1 rectal catheter . 1 rectal catheter used per irrigation respecting the patient usual frequency of transanal irrigation	Device: IryPump R Set

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success of the trans anal irrigation (TAI) procedure	The patient will practice TAI following his usual frequency (depending on his intestinal transit). After each TAI, the patient will evaluate the success of the procedure (defined as satisfying output evacuation of the bowel according to the patient usual pattern in term of volume of water instilled and absence of leakages between 2 irrigations).	Duration of the study per patient will correspond to the realisation of 5 consecutive TAI in a maximum of 41 days of follow up

Collaborators and Investigators

• Sponsor: BBraun Medical SAS
• Investigators: Principal Investigator: Kathleen Charvier, Henry Gabrielle Hospital- St Genis Laval- France

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 10, 2016
• Primary Completion (ACTUAL): June 15, 2017
• Study Completion (ACTUAL): June 15, 2017

Study Registration Dates

• First Submitted: September 20, 2016
• First Submitted That Met QC Criteria: October 25, 2016
• First Posted (ESTIMATE): October 26, 2016

Study Record Updates

• Last Update Posted (ACTUAL): January 25, 2018
• Last Update Submitted That Met QC Criteria: January 23, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases
• Other Study ID Numbers: OPM-G-H-1601; 2016-A00631-50 (OTHER: FRENCH HEALTH AUTORITY)