Clinical Trial Details
— Status: Terminated
Administrative data
NCT number |
NCT04729946 |
Other study ID # |
20-884 |
Secondary ID |
|
Status |
Terminated |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
March 3, 2021 |
Est. completion date |
April 6, 2022 |
Study information
Verified date |
June 2023 |
Source |
The Cleveland Clinic |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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 oral bowel preparation for adequate visualization and hence decreasing time to
colonoscopy and improving diagnostic and therapeutic yield.
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).