Informations générales (source: ClinicalTrials.gov)
A Prospective, Single Center, Single-blinded, Randomized Study, of the Angel of Water™ for Colon Cleansing as Preparation for Colonoscopy
Interventional
N/A
novoGI (Voir sur ClinicalTrials)
juin 2013
mars 2014
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Department of Hepato-Gastroenterology, Nouvel Hopital Civil - Strasbourg - France | Gerard Gay, Prof. | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
1. Subject is >= 18 and ≤ 80 years old, referred to colonoscopy
2. Subject is able and agrees to sign the informed consent and follow the study
requirements
1. Subject is >= 18 and ≤ 80 years old, referred to colonoscopy
2. Subject is able and agrees to sign the informed consent and follow the study
requirements
1. Myocardial infarction within the last 3 months
2. Symptomatic congestive heart failure
3. Established renal failure (serum creatinine > 2.0 mg/dL)
4. Previous abdominal surgery, colectomy, or recent colon or rectal surgery
5. Abdominal hernia
6. Partial or complete intestinal obstruction
7. Acute exacerbation of inflammatory bowel disease
8. Intestinal perforation
9. Fissures or fistula
10. Grade III or IV hemorrhoids
11. Carcinoma of the rectum
12. Distal rectal anastomosis
13. Cirrhosis
14. Hypokalemia
15. Pregnancy
16. Subject's weight > 400 lbs. /182 kg
17. Participation in another study that may affect the results of this study