Status:
TERMINATED
Clinical and Urgent Colonoscopy Outcomes Using the Pure-Vu® Cleansing System
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
Motus GI Medical Technologies Ltd
Conditions:
Lower Gastrointestinal Bleeding
Hemostatic Disorder
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
The Pure-Vu® System can be effectively used as a cleansing device in patients admitted with acute LGIB to the intensive care unit and the regular nurse floor (RNF) bypassing the need to administer an ...
Detailed Description
Acute lower gastrointestinal bleeding (LGIB), while generally defined as gastrointestinal bleeding distal to the ligament of Treitz, can be categorized into small bowel and colorectal bleeding, two si...
Eligibility Criteria
Inclusion
- Hospitalized patients in the ICU or the RNF with acute LGIB (defined as maroon-colored stool or bright red blood per rectum with suspicion of acute blood loss anemia, and hemodynamically stable and/or stabilized at the time of procedure . Hospitalized patients include:
- Patients who develop LGIB while admitted for different reasons
- Patients transferred from an outside hospital for further management of acute LGIB
- Patients admitted through the emergency room for management of acute LGIB
- At least 22 years old
- Undergoing urgent colonoscopy under monitored anesthesia care or conscious sedation
Exclusion
- Suspicion for bowel obstruction/ stricture
- Toxic megacolon or severe colitis (determined by degree of colitis on imaging and clinical condition including pain, fevers, abdominal exam, elevated inflammatory markers)
- Active Diverticulitis
Key Trial Info
Start Date :
March 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 6 2022
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04729946
Start Date
March 3 2021
End Date
April 6 2022
Last Update
June 23 2023
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195