Randomized Controlled Study Comparing Colon Evaluation With The Pure-Vu System To A Standard Colonoscopy In Patients Who Are High Risk For Inadequate Bowel Preparation

Colorectal Cancer Clinical Trial

— RESCue  

Official title:

Randomized Controlled Study Comparing Colon Evaluation With The Pure-Vu System To A Standard Colonoscopy In Patients Who Are High Risk For Inadequate Bowel Preparation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04285008
• Other study ID #: CL00048
• Status: Withdrawn
• Phase: N/A
• Start date: March 3, 2020
• Est. completion date: April 15, 2021

Study information

• Verified date: June 2020
• Source: Motus GI Medical Technologies Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this multi-center, prospective, randomized controlled trial is to evaluate the bowel cleansing after Pure-Vu use in outpatient subjects at high risk for inadequate colon preparation as compare to standard of care.

Description:

Total of 88 subjects (44 per arm) at high risk for inadequate colon preparation will be randomized and undergo procedure either in the Control arm (standard of care) or with the Pure-Vu System.

Subjects will be enrolled at up to 4 clinical sites in the United States.

primary endpoint- A comparison between the two study arms (i.e., Pure-Vu vs. standard colonoscopy) of the rate of overall cleansing as well as cleansing per segment will be evaluated by the BBPS scoring index (Bowel preparation adequacy defined as BBPS >2 in each segment)

The following secondary endpoints will be determined:

1. Assess the willingness of consented subjects to pay for Pure-Vu prior to colonoscopy

2. Colonoscopy procedural measures for Intervention and Control arms

3. Endoscopists' experience

4. Safety assessment for all subjects on the day of procedure per endoscopist

5. Post-colonoscopy patient experience and safety check with scripted phone call 1-3 days after colonoscopy

6. Assess the willingness of consented subjects to pay for the Pure-Vu System 1-3 days after colonoscopy

Follow-up call will be conducted 1-3 business days after the procedure to verify that there has been no change in their clinical status and record their willingness to use the Pure-Vu System in the future.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 15, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

1. Adults > age 22

2. Elective outpatient colonoscopy by participating gastroenterologist

3. Stool clarity grade 1-3 at presentation for colonoscopy

Exclusion Criteria:

1. Not competent to consent

2. Bleeding disorder - known or suspected

3. Hereditary Gastrointestinal Cancer syndrome

4. Known PT INR > 1.5

5. Know elevated PTT

6. Anti-platelet agent or anticoagulant (other than aspirin or nonsteroidal agent) which has not been stopped for the colonoscopy

7. Known platelet count < 50,000

8. Known absolute neutrophil count < 1,000

9. History of surgical colon resection

10. Pre-colonoscopy intent to enter terminal ileum

11. Prior incomplete colonoscopy due to technical & non-bowel preparation related reasons

12. Regular use of non-topical steroid

13. Pregnant

14. Prisoner or institutionalized for any reason

15. Psychiatric illness greater than mild

16. Colonoscopy without anesthesia administered (MAC) sedation

17. Diverticulitis

18. Active inflammatory bowel disease (Crohn's, Ulcerative Colitis, or Indeterminate)

19. Known or suspected colon stricture

Related Conditions & MeSH terms

• Colorectal Cancer
• Digestive System Diseases
• Gastrointestinal Disease
• Gastrointestinal Diseases

Intervention

Device:
• Pure-Vu System
The Pure-Vu System is Food and Drug Administration (FDA) approved device (K191220), 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.

Locations

Country	Name	City	State
United States	Washington University in St. Louis	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Motus GI Medical Technologies Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of adequate cleansing level after using the Pure-Vu System as compare to sandard of care colonoscopy procedure	A comparison between the two study arms (i.e., Pure-Vu vs. standard colonoscopy) of the rate of overall cleansing as well as cleansing per segment will be evaluated by the BBPS scoring index (Bowel preparation adequacy defined as BBPS >2 in each segment)	Up to 2 hours