A Post Marketing Study of Angel of Water™ for Colon Cleansing as Preparation for Colonoscopy

novoGI

Status: Unknown

Conditions: Colon Diseases

Treatments: Device: Colon cleansing by hydrotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT01871584

Hydro-Prep, CLPR-200-0101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

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

Trial design

160 participants in 2 patient groups

Hydrocolonic cleansing

Experimental group

Description:

Subjects undergo colon cleansing by hydrotherapy with the study device

Treatment:

Device: Colon cleansing by hydrotherapy

Standard preparation solution

Active Comparator group

Description:

Subjects undergo colon cleansing by standard preparation solution

Treatment:

Device: Colon cleansing by hydrotherapy