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OpenTrials
Completed

NCT Number: NCT02944916

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

Completed

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Key information

Conditions

Therapeutic Irrigation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

IryPump R Set

Device

Primary outcomes

  1. Success of the trans anal irrigation (TAI) procedure

    Time frame: Duration of the study per patient will correspond to the realisation of 5 consecutive TAI in a maximum of 41 days of follow up

    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).

Sponsors and collaborators

Lead sponsor

BBraun Medical SAS

Industry

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 26, 2016
Registry last updated
Jan 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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