Status:
UNKNOWN
A Post Marketing Study of Angel of Water™ for Colon Cleansing as Preparation for Colonoscopy
Lead Sponsor:
novoGI
Conditions:
Colon Diseases
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 prepa...
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 co...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2014
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT01871584
Start Date
June 1 2013
End Date
March 1 2014
Last Update
June 6 2013
Active Locations (1)
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1
Department of Hepato-Gastroenterology, Nouvel Hopital Civil
Strasbourg, France