Colon DiseasesNCT01871584
A Post Marketing Study of Angel of Water™ for Colon Cleansing as Preparation for Colonoscopy
A study testing Colon cleansing by hydrotherapy in people with Colon Diseases, run by novoGI at 1 site in France.
Trial summary
The aim of this study is to demonstrate the efficacy of the hydrocolonic lavage method in order to prepare the colon prior to performing a colonoscopy, by comparison the hydrotherapy to standard preparation solution. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colon Diseases
- What is being tested?
- Colon cleansing by hydrotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2013to Mar 2014
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is >= 18 and ≤ 80 years old, referred to colonoscopy
- Subject is able and agrees to sign the informed consent and follow the study requirements
Who cannot join
- Myocardial infarction within the last 3 months
- Symptomatic congestive heart failure
- Established renal failure (serum creatinine > 2.0 mg/dL)
- Previous abdominal surgery, colectomy, or recent colon or rectal surgery
- Abdominal hernia
- Partial or complete intestinal obstruction
Show all 17Show fewer
- Acute exacerbation of inflammatory bowel disease
- Intestinal perforation
- Fissures or fistula
- Grade III or IV hemorrhoids
- Carcinoma of the rectum
- Distal rectal anastomosis
- Cirrhosis
- Hypokalemia
- Pregnancy
- Subject's weight > 400 lbs. /182 kg
- Participation in another study that may affect the results of this study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Department of Hepato-Gastroenterology, Nouvel Hopital Civil
Strasbourg
Gerard Gay, Prof., +33 369 55 03 13, gerard.gay@chru-strasbourg.fr
Michel Delvaux, Prof., +33-369 55 03 13, michel.delvaux@chru-strasbourg.fr
About this study
Official title: A Prospective, Single Center, Single-blinded, Randomized Study, of the Angel of Water™ for Colon Cleansing as Preparation for Colonoscopy
The aim of this study is to demonstrate the efficacy of the hydrocolonic lavage method in order to prepare the colon prior to performing a colonoscopy, by comparison the hydrotherapy to standard preparation solution.
Hypothesis: Colon cleansing by hydrotherapy is as good as colon cleansing by standard preparation solution.
Read the detailed description
Colonoscopy is the current standard method for evaluation of the colon. It has an indispensable place in the diagnosis and treatment of colon diseases. Diagnostic accuracy and therapeutic safety of colonoscopy depends on the quality of the colonic cleansing or preparation. Good preparation of the bowel is necessary prior to colonoscopy, to allow clear visualization of the bowel wall and any pathology within. The proposed study is a post-marketing study in which the study device, the Angel of Water system will be used for hydrotherapy of the colon in adult subjects scheduled for elective colonoscopy, instead of standard preparation solution. The effectiveness of the hydrotherapy in comparison to the standard preparation will be defined by evaluating colon cleanliness, subject's attitude and the duration of colonoscopy procedure.
- Conditions
- Colon Diseases
- Being tested
- Colon cleansing by hydrotherapy
- Keywords
- A colon hydrotherapy system, Hydrocolonic preparation, Preparation for colonoscopy
- Medical subject headings
- Colonic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colon cleansing by hydrotherapyDevice
Also called The Angel of Water™, a colon hydrotherapy system.
The Angel of Water™ system will be used for hydrotherapy of the colon in adult subjects scheduled for elective colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Hydrocolonic cleansing | Experimental | Subjects undergo colon cleansing by hydrotherapy with the study device Receives: Device: Colon cleansing by hydrotherapy |
| Standard preparation solution | Active comparator | Subjects undergo colon cleansing by standard preparation solution Receives: Device: Colon cleansing by hydrotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colon Cleanliness during colonoscopy according to Boston Bowel Preparation Scale (BBPS)
The primary study outcome is the Boston Bowel Preparation Scale (BBPS) score evaluating during colonoscopy. The BBPS is a valid scale for measuring bowel preparation as well as colonoscopy outcomes, as it reflects the colon's cleanliness during the inspection phase of the procedure.
Measured: Per patient: the end of procedure; For study: approx. 10 months
Secondary outcomes (1)
Subject's Attitude: rating the preparation procedure with respect to ease, convenience and comfort
Each subject will be asked to answer post cleansing questionnaire and a score will be calculated.
Measured: Per patient: the end of procedure; For study: approx. 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionMar 2014 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon DiseasesStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- novoGI
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eran Choman, Study director, novoGI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01871584
- Sponsor's protocol ID
- Hydro-Prep, CLPR-200-0101
- Status last verified
- Jun 2013
- First submitted
- 4 Jun 2013
- Last updated
- 6 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Center, Single-blinded, Randomized Study, of the Angel of Water™ for Colon Cleansing as Preparation for Colonoscopy
- ClinicalTrials.gov ID
- NCT01871584
- Acronym / sponsor ID
- Hydro-Prep, CLPR-200-0101
- Conditions
- Colon Diseases
- Keywords
- A colon hydrotherapy system, Hydrocolonic preparation, Preparation for colonoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- novoGIIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 6 Jun 2013 (estimated)
- 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.
The aim of this study is to demonstrate the efficacy of the hydrocolonic lavage method in order to prepare the colon prior to performing a colonoscopy, by comparison the hydrotherapy to standard preparation solution.
Hypothesis: Colon cleansing by hydrotherapy is as good as colon cleansing by standard preparation solution.
Detailed description
Colonoscopy is the current standard method for evaluation of the colon. It has an indispensable place in the diagnosis and treatment of colon diseases. Diagnostic accuracy and therapeutic safety of colonoscopy depends on the quality of the colonic cleansing or preparation. Good preparation of the bowel is necessary prior to colonoscopy, to allow clear visualization of the bowel wall and any pathology within. The proposed study is a post-marketing study in which the study device, the Angel of Water system will be used for hydrotherapy of the colon in adult subjects scheduled for elective colonoscopy, instead of standard preparation solution. The effectiveness of the hydrotherapy in comparison to the standard preparation will be defined by evaluating colon cleanliness, subject's attitude and the duration of colonoscopy procedure.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrocolonic cleansing | Experimental | Device: Colon cleansing by hydrotherapySubjects undergo colon cleansing by hydrotherapy with the study device |
| Standard preparation solution | Active comparator | Device: Colon cleansing by hydrotherapySubjects undergo colon cleansing by standard preparation solution |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject is >= 18 and ≤ 80 years old, referred to colonoscopy
- Subject is able and agrees to sign the informed consent and follow the study requirements
Key exclusion criteria (17 listed)
- Myocardial infarction within the last 3 months
- Symptomatic congestive heart failure
- Established renal failure (serum creatinine > 2.0 mg/dL)
- Previous abdominal surgery, colectomy, or recent colon or rectal surgery
- Abdominal hernia
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 |
|---|---|---|
| Colon cleansing by hydrotherapyAlso: The Angel of Water™, a colon hydrotherapy system.The Angel of Water™ system will be used for hydrotherapy of the colon in adult subjects scheduled for elective colonoscopy. | Device | Hydrocolonic cleansing, Standard preparation solution |
Primary outcome
Colon Cleanliness during colonoscopy according to Boston Bowel Preparation Scale (BBPS)
Time frame: Per patient: the end of procedure; For study: approx. 10 months
The primary study outcome is the Boston Bowel Preparation Scale (BBPS) score evaluating during colonoscopy. The BBPS is a valid scale for measuring bowel preparation as well as colonoscopy outcomes, as it reflects the colon's cleanliness during the inspection phase of the procedure.
1 secondary outcome
Subject's Attitude: rating the preparation procedure with respect to ease, convenience and comfort
Time frame: Per patient: the end of procedure; For study: approx. 10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2013.
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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.
Eran Choman study director
novoGI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colon cleansing by hydrotherapy in people with Colon Diseases, run by novoGI at 1 site in France.
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 2 inclusion and 17 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 6 Jun 2013. 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 France. 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 Eran Choman (+972-9-860 3016, Eran.Choman@novogi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colon Cleanliness during colonoscopy according to Boston Bowel Preparation Scale (BBPS) (time frame: Per patient: the end of procedure; For study: approx. 10 months). 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 6 Jun 2013.