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

NCT02944916 | Completed

• 2 other identifiers: OPM-G-H-16012016-A00631-50
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Therapeutic Irrigation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

IryPump R Set

EXPERIMENTAL

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

Interventions

IryPump R Set DEVICE

IryPump R Set

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is at least 18 years old,
• Patient having signed an informed consent
• 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.
• Patient practicing TAI on the basis of 1 procedure/ week as a minimum or more frequently
• Patient capable to perform the procedure of transanal irrigation himself or with the help of a caregiver
• Patient having a mental capacity to participate to the study (i.e. to understand the study and to answer to the questions)
• Patient agrees to test IryPump® Set R for a time corresponding to 5 consecutive irrigations and a maximum of 4 weeks.
• Patient covered by social security

You may not qualify if:

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

Sponsors & Collaborators

• BBraun Medical SAS: lead

Study Officials

• Kathleen Charvier

  Henry Gabrielle Hospital- St Genis Laval- France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2016
• First Posted: October 26, 2016
• Study Start: November 10, 2016
• Primary Completion: June 15, 2017
• Study Completion: June 15, 2017
• Last Updated: January 25, 2018

Record last verified: 2018-01