Optimizing the Preparation Regime Prior to Colonoscopy Procedure With Pure-Vu System

NCT03493009 | Withdrawn

• 1 other identifier: CL00042
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this multicenter, prospective, randomized study is to evaluate the performance of Pure-Vu System in cleansing patients' colon who are indicated for a colonoscopy procedure using one of two different reduce bowel preparation regimes.in addition, the cecum intubation rate, time to cecum, total procedure time, and adverse event will be evaluated.

Conditions

Gastrointestinal Diseases; Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• rate of adequate cleansing level

  The rate of adequate cleansing level in each colon segment before and after use of Pure-Vu will be evaluated per study arm using the Boston Bowel Preparation Scale (BBPS). Segment score of 0-3 given to each of the 3 segments of the colon (Left side, Transverse and right side). BBPS\* scores will be rated by the colonoscopies, on the basis of three segment scores summed for maximum score of 9, where: * 0 = unprepared * 9 = completely clean (in completed to Cecum procedures) An adequate cleansing procedure will be considered when all the colon segments will be graded as 2 or above.

  up to 2 hours

Study Arms (2)

10mg Magnesium citrate

EXPERIMENTAL

subjects will be required to follow a specific bowel preparation instruction consisting of dietary restrictions (no dried fruit, seeds or nuts) starting 5 days prior to the colonoscopy, an low residue diet at the day before the procedure, followed by a split dose of 10 mg of Magnesium citrate, followed by colonoscopy procedure with Pure-Vu System

Device: Pure-Vu System

15mg Magnesium citrate

EXPERIMENTAL

subjects will be required to follow a specific bowel preparation instruction consisting of dietary restrictions (no dried fruit, seeds or nuts) starting 5 days prior to the colonoscopy, an low residue diet at the day before the procedure, followed by a split dose of 15 mg of Magnesium citrate, followed by colonoscopy procedure with Pure-Vu System

Device: Pure-Vu System

Interventions

Pure-Vu System DEVICE

The Pure-Vu System is Food and Drug Administration (FDA) approved device since September 22, 2016, intended to connect to standard colonoscopes to help facilitate intra-procedural cleaning of a poorly prepared colon by irrigating or cleaning the colon and evacuating the irrigation fluid (water), feces and other bodily fluids and matter, e.g. blood.

10mg Magnesium citrate; 15mg Magnesium citrate

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects scheduled for colonoscopy procedure
• Subjects in the age range of 22-75 years inclusive
• Subject is willing and able to participate in the study procedures and to understand and sign the informed consent.

You may not qualify if:

• Patients with active Inflammatory Bowel Disease
• Patients with known diverticulitis disease or with prior incomplete colonoscopy due to diverticular disease
• Patients with known bowel obstruction
• Patient with chronic constipation
• History of prior surgery to colon and/or rectum
• ASA (Physical status classification system) ≥ III
• Renal insufficiency (Creatinine ≥ 1.5mg /dL) (based on medical history)
• Abnormal Liver enzymes (ALT/AST ≥ 2 times upper limits of normal) (based on medical history)
• Patients taking anticoagulants drugs (excluding aspirin) or dual antiplatelet therapy
• Patients with known coagulation disorder (INR \>1.5).
• Pregnancy (as stated by patient) or breast feeding
• Patients with altered mental status/inability to provide informed consent

Sponsors & Collaborators

• Motus GI Medical Technologies Ltd: lead

MeSH Terms

Conditions

Gastrointestinal Diseases; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No blinding is applicable in this study .
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomization in blocks will be applied for each site to allocate patients to one of two different bowel preparation regimens (Prep A- split doae of 10mg of Magnesium citrate versus Prep B- split doae of 15mg of Magnesium citrate). The study will utilize randomization in blocks using the standard envelope procedure, which will be applied in order to allocate patients into two arms: * Group 1 - Will go through the Prep A procedure * Group 2 - Will go through the Prep B procedure The site randomization plan will be provided to the study coordinator prior the study start.

Study Record Dates

• First Submitted: December 27, 2017
• First Posted: April 10, 2018
• Study Start: May 1, 2018
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: October 31, 2018

Record last verified: 2017-12