Colonic IrrigationNCT04684082
Evaluation of Performance and Safety of Colonic Irrigation With the Colon Hydromat as a Non-oral Bowel Preparation for Colonoscopy
An observational study of Colonic Irrigation, run by Herrmann Apparatebau GmbH at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Irrigation
- What is being tested?
- Colonic irrigation with the Colon Hydromat
- Type of treatment
- Medical device
- How many people
- 28 participants
- Where
- 1 siteGermany
- Study dates
- 3 Feb 2021to 30 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients with an indication of colonoscopy: inclusion is considered if patients require a colonoscopy and
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Internistische Gemeinschaftspraxis für Verdauungs- und Stoffwechselerkrankungen
Leipzig, 04105
Niels Teich, Prof., +49 34204 7200, teich@igvs.de
About this study
Official title: Prospective, Single-center, Single-arm, Open-label Observational PMCF Study - Evaluation of Performance and Safety of Colonic Irrigation With the Colon Hydromat as a Non-oral Bowel Preparation for Colonoscopy
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.
Read the detailed description
This observational study is intended to answer the question, if the colon hydrotherapy (colonic irrigation with the "Colon Hydromat") works in real-life practice.
Colonic irrigation is regarded as a substitute for standard oral colonic purgative solutions for colonoscopy preparation. The advantage of colonic irrigation is that there is no unpleasant taste, it avoids the discomfort of diarrheic episode and there is no need to drink a large volume of water or fluids. The patient will receive the bowel irrigation with the "Colon Hydromat" directly before colonoscopy, at the same day. Aim of this study is to confirm performance (effectiveness), in terms of an adequate bowel preparation and safety of the "Colon-Hydromat", as alternative bowel cleansing device prior to colonoscopy. The primary performance (effectiveness) endpoint for this study is the colonic cleanliness, defined as overall quality of bowel cleansing as measured by the Boston Bowel Preparation Scale (BBPS). The primary safety endpoints for this study are adverse device events (ADE) and serious adverse device effects (SADE), product and procedure related.
- Conditions
- Colonic Irrigation
- Being tested
- Colonic irrigation with the Colon Hydromat
- Keywords
- Colon Hydrotherapy, Colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colonic irrigation with the Colon HydromatDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Single Group Assignment | Patients will receive colonic irrigation as bowel preparation prior to colonoscopy. Receives: Device: Colonic irrigation with the Colon Hydromat |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: day 1
Secondary outcomes (12)
BBPS for each segment.
BBPS will be assessed in each bowel segment (left, transverse, right).
Measured: day 1
Patient satisfaction.
Patient satisfaction with respect to convenience and comfort/ discomfort, and preference/acceptance, as evaluated by a questionnaire (questions to the patient; no score).
Measured: day 1
User satisfaction and usability.
User satisfaction and usability, as measured by a questionnaire (questions to the patient; no score).
Measured: day 1
Details to colonic irrigation.
Time taken to complete the colon irrigation with the "Colon Hydromat".
Measured: day 1
Details to colonic irrigation.
Number of cycles used for cleaning the colon.
Measured: day 1
Details to colonic irrigation.
Volume of water used for cleaning the colon.
Measured: day 1
Colonoscopic findings.
Characteristics of all polyps/lesions detected:
Location (right, transverse, or left colon) and size.
General assessment of colon anatomy and other circumstances related to the colon:
No abnormality detected / tortuous / very long/ diverticular disease / stenosis / severe constipation / weak muscle tone of the sphincter - build-up of pressure was insufficient.
Measured: day 1
Rate of colonoscopy termination.
Rate of colonoscopy termination due to inadequate bowel preparation.
Measured: day 1
Procedure time of colonoscopy.
Procedure time of colonoscopy (time from intubation to withdrawal).
Measured: day 1
Withdrawal time.
Withdrawal time: the total time for withdrawal from cecum to anus; this includes all interventions or delays (e.g. biopsies, polypectomies…).
Measured: day 1
Cecal intubation rate.
Cecal intubation rate (reaching the cecum or anastomosis, if present).
Measured: day 1
Runway time.
Time interval between the patient's end of bowel cleaning / colonic irrigation and the moment of colonoscope insertion.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start3 Feb 2021 (estimated)
- Primary completion15 Mar 2021 (estimated)
- Study completion30 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic IrrigationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herrmann Apparatebau GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CERES GmbH
- Responsible party
- Sponsor
- Investigators
- Niels Teich, Prof. Dr. med., Principal investigator, Study centre Leipzig - Internistic Joint Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04684082
- Sponsor's protocol ID
- HRR015CHT
- Status last verified
- Dec 2020
- First submitted
- 16 Dec 2020
- Last updated
- 8 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single-center, Single-arm, Open-label Observational PMCF Study - Evaluation of Performance and Safety of Colonic Irrigation With the Colon Hydromat as a Non-oral Bowel Preparation for Colonoscopy
- ClinicalTrials.gov ID
- NCT04684082
- Acronym / sponsor ID
- HRR015CHT
- Conditions
- Colonic Irrigation
- Keywords
- Colon Hydrotherapy, Colonoscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Herrmann Apparatebau GmbHIndustry (pharma, biotech, devices)
- Collaborators
- CERES GmbH
- Study start
- 3 Feb 2021 (estimated)
- Primary completion
- 15 Mar 2021 (estimated)
- Study completion
- 30 Mar 2021 (estimated)
- First posted
- 24 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This observational study is intended to answer the question, if the colon hydrotherapy (colonic irrigation with the "Colon Hydromat") works in real-life practice.
Colonic irrigation is regarded as a substitute for standard oral colonic purgative solutions for colonoscopy preparation. The advantage of colonic irrigation is that there is no unpleasant taste, it avoids the discomfort of diarrheic episode and there is no need to drink a large volume of water or fluids. The patient will receive the bowel irrigation with the "Colon Hydromat" directly before colonoscopy, at the same day. Aim of this study is to confirm performance (effectiveness), in terms of an adequate bowel preparation and safety of the "Colon-Hydromat", as alternative bowel cleansing device prior to colonoscopy. The primary performance (effectiveness) endpoint for this study is the colonic cleanliness, defined as overall quality of bowel cleansing as measured by the Boston Bowel Preparation Scale (BBPS). The primary safety endpoints for this study are adverse device events (ADE) and serious adverse device effects (SADE), product and procedure related.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group Assignment | – | Device: Colonic irrigation with the Colon HydromatPatients will receive colonic irrigation as bowel preparation prior to colonoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Patients with an indication of colonoscopy: inclusion is considered if patients require a colonoscopy and
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colonic irrigation with the Colon HydromatA 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. | Device | Single Group Assignment |
Primary outcome
Quality of bowel preparation (Colonic Cleanliness), evaluated through the Boston Bowel Preparation Scale (BBPS).
Time frame: day 1
Quality of bowel preparation validated by numerical scale for bowel cleanse (0-9 best)
Adverse device events (ADE) and collection of SADE (device or procedure related).
Time frame: day 1
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.
12 secondary outcomes
BBPS for each segment.
Time frame: day 1
Patient satisfaction.
Time frame: day 1
User satisfaction and usability.
Time frame: day 1
Details to colonic irrigation.
Time frame: day 1
Details to colonic irrigation.
Time frame: day 1
Details to colonic irrigation.
Time frame: day 1
Colonoscopic findings.
Time frame: day 1
Rate of colonoscopy termination.
Time frame: day 1
Procedure time of colonoscopy.
Time frame: day 1
Withdrawal time.
Time frame: day 1
Cecal intubation rate.
Time frame: day 1
Runway time.
Time frame: day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niels Teich, Prof. Dr. med. principal investigator
Study centre Leipzig - Internistic Joint Practice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonic Irrigation, run by Herrmann Apparatebau GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jochen Huebner (+49 6022 65813, jhuebner@hab.gmbh), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of bowel preparation (Colonic Cleanliness), evaluated through the Boston Bowel Preparation Scale (BBPS). (time frame: day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2021.