Evaluation of Performance and Safety of Colonic Irrigation With the Colon Hydromat as a Non-oral Bowel Preparation for Colonoscopy

NCT04684082 | Unknown

• 1 other identifier: HRR015CHT
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This is a clinical study with a medical device that bears the CE mark (approval for marketing in the EU) and is applied within its intended use. It is a prospective, single-centre, single-arm, open-label, observational post-market clinical follow-up (PMCF) study using the "Colon Hydromat" system for bowel preparation prior to colonoscopy. The patients will be treated according to the clinical routine and in accordance with the current IFU. Aim of the study is to confirm safety and performance (effectiveness) of colon hydrotherapy as bowel preparation for colonoscopy. Colonic irrigation is regarded as a substitute for standard oral colonic purgative solutions for colonoscopy preparation, especially for patients, who cannot tolerate oral preparations or want to have alternatives because they have experienced the current oral preparations as a burdensome process.

Conditions

Colonic Irrigation

Keywords

Colon Hydrotherapy; Colonoscopy

Outcome Measures

Primary Outcomes (2)

• Quality of bowel preparation (Colonic Cleanliness), evaluated through the Boston Bowel Preparation Scale (BBPS).

  Quality of bowel preparation validated by numerical scale for bowel cleanse (0-9 best)

  day 1

• Adverse device events (ADE) and collection of SADE (device or procedure related).

  Assessment of ADE: Patients will be asked in questionnaires, if they had any adverse events, especially nausea, vomiting, pain/cramps, dizziness and headache and rate of patients where colonic irrigation had to be aborted. Assessment of SADE: will be assessed at end of colonoscopy by investigator.

  day 1

Secondary Outcomes (12)

• BBPS for each segment.

  day 1

• Patient satisfaction.

  day 1

• User satisfaction and usability.

  day 1

• Details to colonic irrigation.

  day 1

• Details to colonic irrigation.

  day 1

Study Arms (1)

Single Group Assignment

Patients will receive colonic irrigation as bowel preparation prior to colonoscopy.

Device: Colonic irrigation with the Colon Hydromat

Interventions

Colonic irrigation with the Colon Hydromat DEVICE

A designated health professional will administer to the patient the colonic irrigation procedure - using the "Colon Hydromat" device, a CE certified device for colonic irrigation and cleansing before endoscopic procedures.

Single Group Assignment

Eligibility Criteria

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

Study Population

All patients (men and women) who are planned for a colonoscopy and where anorectal colonic irrigation with the specula can be performed, will be included into the study. The colonic irrigation is regarded as alternative bowel preparation to oral preparations, especially for patients who: * cannot tolerate oral preparations (e.g. cannot drink large volumes, nausea, vomiting), or * want to have alternatives because they have experienced the current oral preparations as a burdensome process, or * had an inadequate colon cleansing following traditional oral preparation, in order to complete the colonoscopy at the same day.

You may qualify if:

• desire an alternative bowel preparation method to standard of oral polyethylene glycol or other orally taken purgatives, or do not tolerate the oral preparations, or had an inadequate colon cleansing following traditional oral preparation, in order to complete the colonoscopy at the same day.
• Adult patients (≥ 18 years old) having signed the informed consent.
• Being able to respond to the self-administered questionnaire.

You may not qualify if:

• Psychiatric conditions and inability to provide informed consent
• Emergency colonoscopy
• Off-label use (application is not within the IFU)
• Pregnancy and lactation period
• The patient has one of the contraindications listed in the IFU.

Sponsors & Collaborators

• Herrmann Apparatebau GmbH: lead
• CERES GmbH: collaborator

Study Sites (1)

Internistische Gemeinschaftspraxis für Verdauungs- und Stoffwechselerkrankungen

Leipzig, 04105, Germany

RECRUITING

Study Officials

• Niels Teich, Prof. Dr. med.

  Study centre Leipzig - Internistic Joint Practice

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jochen Huebner

CONTACT

+49 6022 65813; jhuebner@hab.gmbh

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: December 24, 2020
• Study Start: February 3, 2021
• Primary Completion: March 15, 2021
• Study Completion: March 30, 2021
• Last Updated: February 8, 2021

Record last verified: 2020-12

Locations

DE (1)