- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04729946
Clinical and Urgent Colonoscopy Outcomes Using the Pure-Vu® Cleansing System
June 21, 2023 updated by: Brian Baggott, The Cleveland Clinic
Clinical and Urgent Colonoscopy Outcomes Using the Pure-Vu® Cleansing System in Hospitalized Patients With Lower Gastrointestinal Bleeding: A Single-Center Prospective Pilot Study
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 oral bowel preparation for adequate visualization and hence decreasing time to colonoscopy and improving diagnostic and therapeutic yield.
Study Overview
Status
Terminated
Intervention / Treatment
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 sites with distinct presentations as well as diagnostic and management options (1).
Acute LGIB secondary to a colorectal source usually presents with sudden onset hematochezia with or without acute blood loss anemia and hemodynamic instability, and usually leads to multiple invasive procedures and hospitalizations.
It accounts for up to one-third of all hospitalizations related to GIB (2).
The current guidelines recommend urgent colonoscopy to be performed within 8 to 24 hours of presentation and after adequate colon preparation to improve visualization and diagnostic/therapeutic yield (1).
While studies looking at optimal timing of colonoscopy are limited for patients with acute LGIB, a study comparing 48 patients with diverticular bleeding who underwent colonoscopy after rapid polyethylene glycol (PEG) preparation and within 12 hours of presentation with endoscopic hemostasis compared to 73 controls without endoscopic hemostasis, found a significant improvement in outcomes in the group that underwent hemostasis, including bleeding (0% vs. 53%) and hospital length (median of 2 days vs. 5 days) (3).
In another RCT of 100 patients presenting with LGIB, colonoscopy within 8 hours of presentation after rapid preparation lead to a more definite diagnosis compared to patients who underwent elective colonoscopy within 96 hours of presentation (4).
Urgent colonoscopy however requires the rapid administration of a large volume bowel preparation over 3-4 hours until the rectal effluent is clear (1).
Purge preparation can be challenging in critically ill patients and frequently requires the placement of a nasogastric tube for administration of the preparation which could place the patient at risk of aspiration, poor tolerance, and rarely, electrolyte imbalances (1).
Moreover, bleeding can subside while awaiting resuscitation and bowel preparation prior to endoscopic intervention, which could lead to a decreased diagnostic and therapeutic yield.
The guidelines recommend against unprepped colonoscopy due to poor visualization and increased perforation risk (1).
A pilot study looked at the effect of "hydroflush colonoscopy" in acute LGIB with minimally prepped colons (tap water enema without oral preparation).
"Hydroflush colonoscopy" was defined as colonoscopy using a combination of a water jet pump irrigation and a mechanical endoscope suction device (BioVac direct suction device).
Out of the 12 patients included, the cecum was reached 69% of the time and endoscopic visualization was found to be adequate to find the source of bleeding in all procedures (5).
The Pure-Vu® System (MotusGI Ltd.), a novel Food and Drug Administration (FDA) 510k cleared intra-procedural cleansing device, has been recently introduced.
The Pure-Vu® System integrates with the colonoscope and generates a pulsed vortex mixture of water and air in order to remove debris and is active at the time of cleansing to evacuate colonic contents simultaneously (6).
Its effectiveness has been studied in colonoscopies requiring minimal preparation regimens with excellent and safe results (7,8).
A multicenter European feasibility study looked at 47 patients referred for colonoscopy who received a limited bowel preparation and found significant improvement in the proportion of patients with adequate preparation, with a median Boston bowel preparation score (BBPS) increased from 3[0-5] to 9 [8-9] (8).
The REDUCE trial (9), another multicenter, single-arm study, was the first trial to study Pure-Vu® in the inpatient setting, which enrolled 95 hospitalized subjects.
Adequate bowel preparation improved from 38% (95% CI 28,49) to 96% (CI 90-99) in the evaluated segments.
The mean BBPS improved from 1.74 in the left colon, 1.74 in the transverse colon, 1.5 in the right colon to 2.89, 2.91 and 2.86 respectively (p<0.001) (9).
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- Cleveland Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
22 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
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 Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pure-Vu Treatment
Participants in this arm will undergo colonoscopy using the Pure-Vu cleansing device.
|
The Pure-Vu device attaches to the colonoscope and provides colonic cleansing during urgent colonoscopy without the need for a bowel preparation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adequate Bowel Preparation
Time Frame: During the colonoscopy procedure, typically less than 1 hour
|
The proportion of participants who achieve an adequate bowel preparation to identify bleeding lesions
|
During the colonoscopy procedure, typically less than 1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnostic yield
Time Frame: During the colonoscopy procedure, typically less than 1 hour
|
The frequency with which investigators are able to successfully identify the source of bleeding.
|
During the colonoscopy procedure, typically less than 1 hour
|
Therapeutic Yield
Time Frame: During the colonoscopy procedure, typically less than 1 hour
|
The frequency with which investigators are able to successfully control bleeding through endoscopic intervention
|
During the colonoscopy procedure, typically less than 1 hour
|
Re-bleeding rate
Time Frame: 48 hours post-colonoscopy
|
The proportion of participants who experience recurrence of bleeding
|
48 hours post-colonoscopy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Brian Baggott, MD, The Cleveland Clinic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 3, 2021
Primary Completion (Actual)
April 6, 2022
Study Completion (Actual)
April 6, 2022
Study Registration Dates
First Submitted
January 25, 2021
First Submitted That Met QC Criteria
January 25, 2021
First Posted (Actual)
January 29, 2021
Study Record Updates
Last Update Posted (Actual)
June 23, 2023
Last Update Submitted That Met QC Criteria
June 21, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-884
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lower Gastrointestinal Bleeding
-
Lawson Health Research InstituteMcGill University; University of Alberta; University of Oxford; Western University... and other collaboratorsCompleted
-
Sohag UniversityNot yet recruitingUpper and Lower Gastrointestinal Bleeding
-
Beijing Friendship HospitalRecruitingAcute Lower Gastrointestinal BleedingChina
-
Tokyo UniversityCompleted
-
Valduce HospitalCompleted
-
Groupe Hospitalier Paris Saint JosephCompletedColorectal Surgery | Proctology | Lower Gastrointestinal TractFrance
-
Waihong ChungUnknownMetoclopramide, Azithromycin, or Nondrug Pretreatment for UGIB to Reduce Second Endoscopy (MANPURSE)Upper Gastrointestinal Bleeding | Gastro Intestinal BleedingUnited States
-
Ottawa Hospital Research InstituteRecruitingGastroIntestinal Bleeding | Anticoagulant-induced BleedingCanada
-
Boston Children's HospitalBaylor College of Medicine; Children's Hospital of Philadelphia; Ann & Robert... and other collaboratorsRecruitingUpper Gastrointestinal Bleeding | Gastro Intestinal BleedingUnited States
Clinical Trials on Pure-Vu Cleansing Device
-
Motus GI Medical Technologies LtdRecruiting
-
Radboud University Medical CenterMotus GI Medical Technologies Ltd; University Medical Center MainzCompletedColorectal Cancer | Bowel Preparation | Colonic AdenomaGermany, Netherlands
-
Motus GI Medical Technologies LtdCompletedColorectal Cancer | Gastrointestinal DiseaseUnited States
-
Motus GI Medical Technologies LtdTerminated
-
Motus GI Medical Technologies LtdWithdrawnColorectal Cancer | Gastrointestinal DiseaseUnited States
-
Children's Hospital Medical Center, CincinnatiRecruitingCardiac Anomaly | Pectus ExcavatumUnited States
-
Motus GI Medical Technologies LtdWithdrawnGastrointestinal Diseases | Colorectal Cancer
-
Johns Hopkins UniversityNational Heart, Lung, and Blood Institute (NHLBI); Perceptive Navigation LLCNot yet recruiting
-
Barcelona Institute for Global HealthRecercaixa; Centre de Recerca per a l'Educació Científica i Matemàtica (CRECIM) and other collaboratorsCompletedRisk Behavior | Attention Impaired | Risk-Taking | Social Preferences | Decision Making | AttentionSpain