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NCT03503162

Evaluation of the Bowel Cleansing in Hospitalized Patients Using Pure-Vu System

Completed NA Results posted Last updated 13 April 2021
What this trial tests

NA trial testing Pure-Vu System in Gastrointestinal Disease in 95 participants. Completed in 20 May 2019.

Timeline
17 May 2018
Primary endpoint
20 May 2019
20 May 2019

Quick facts

Lead sponsorMotus GI Medical Technologies Ltd
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposescreening
Enrollment95
Start date17 May 2018
Primary completion20 May 2019
Estimated completion20 May 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Motus GI Medical Technologies Ltd

Who can join

22 and older, any sex, with Gastrointestinal Disease or Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Rate of Adequate Cleansing Level Before and After the Use of the Pure-Vu System Primary · up to 2 hours

The rate of adequate cleansing level in each colon segment before and after use of Pure-Vu will be evaluated 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) summed for the maximum score of 9 (0= dirtiest and 9= pristine). An adequate cleansing procedure will be considered when all the colon segments will be graded as 2 or above.

Rate of adequate preparation measured by BBPS before Pure-Vu Use
GroupValue95% CI
Colonoscopy With Pure-Vu System3828 – 49
Rate of adequate preparation measured by BBPS after Pure-Vu Use
GroupValue95% CI
Colonoscopy With Pure-Vu System9690 – 99

Adverse events — posted to ClinicalTrials.gov

Time frame: From procedure to 48 hours post procedure. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Colonoscopy With Pure-Vu System
Serious: 1/94 (1%)
Deaths: 0/94

Serious adverse events (1 terms)

ReactionSystemColonoscopy With Pure-Vu S…
PerforationGastrointestinal disorders
Other adverse events (3 terms — click to expand)

ReactionSystemColonoscopy With Pure-Vu S…
FeverGastrointestinal disorders
abdominal painGastrointestinal disorders
Drop in HemoglobinGastrointestinal disorders

Most-reported serious reactions: Perforation.

Data from ClinicalTrials.gov NCT03503162 adverse events section.

Sponsor's own description

The aim of this study is to evaluate the potential improvement in colonoscopy procedure's outcomes when using the Pure-Vu System in hospitalized patients who are indicated for colonoscopy procedure.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. A multicenter, prospective, inpatient feasibility study to evaluate the use of an intra-colonoscopy cleansing device to optimize colon preparation in hospitalized patients: the REDUCE study.
    Neumann H, Latorre M, Zimmerman T, Lang G, et al · · 2021 · cited 7× · PMID 34022813 · DOI 10.1186/s12876-021-01817-2

Verify or expand the search:

Other trials of Pure-Vu System

Trials testing the same drug.

Other recruiting trials for Gastrointestinal Disease

Currently open trials in the same condition.

Other Motus GI Medical Technologies Ltd trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03503162.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing