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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.
This multi-center, prospective, single arm study will include up to 100 patients (20-40 patients per site), aimed at evaluating the performance of the Pure-Vu System in cleansing hospitalized patients' colon who are indicated for standard colonoscopy procedure.
Subjects will be enrolled at up to 4 clinical sites in the United States and Europe. Subjects who meet the eligibility criteria will be prescribed a standard bowel preparation bowel preparation regimen including diet restrictions and oral bowel preparation.
Following the bowel preparation, the patient will undergo colonoscopy with the Pure-Vu system.
In case of inadequate bowel preparation, as per the nurse report and / or BBPS < 2, in at least one of the colon segments, prior Pure-Vu use, the physician will complete a questionnaire on the patient's management standard of care assuming the absence of Pure-Vu.
Follow-up will be conducted at 48 hours (± 48 hours) post procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colonoscopy with Pure-Vu System | Experimental | Standard colonoscopy procedure with Pure-Vu System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pure-Vu System | Device | The Pure-Vu System is FDA cleared device and CE marking received in February 2018, 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The Rate of Adequate Cleansing Level Before and After the Use of the Pure-Vu System | 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. | up to 2 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Annie Choi | Motus GI Technologies Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34022813 | Derived | Neumann H, Latorre M, Zimmerman T, Lang G, Samarasena J, Gross S, Brahmbhatt B, Pazwash H, Kushnir V. 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. BMC Gastroenterol. 2021 May 22;21(1):232. doi: 10.1186/s12876-021-01817-2. |
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no plan to share the individual participated date with other researchers at this point.
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| ID | Title | Description |
|---|---|---|
| FG000 | Colonoscopy With Pure-Vu System | Inpatient colonoscopies with Pure-Vu System- Single Arm Pure-Vu System: The Pure-Vu System is FDA cleared device 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Colonoscopy With Pure-Vu System | Inpatient colonoscopies with Pure-Vu System- Single Arm Pure-Vu System: The Pure-Vu System is FDA cleared device 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Rate of Adequate Cleansing Level Before and After the Use of the Pure-Vu System | 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 Adequacy of bowel preparation using the Boston Bowel Preparation Score (BBPS) | Posted | Mean | 95% Confidence Interval | Percentage of Adequate cleansing | up to 2 hours |
|
From procedure to 48 hours post procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Colonoscopy With Pure-Vu System | Inpatient colonoscopy procedure with Pure-Vu System Pure-Vu System: The Pure-Vu System is FDA cleared device and CE marking received in February 2018, 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Perforation | Gastrointestinal disorders | Non-systematic Assessment | After procedure patient reported abdominal pain. Exploratory laparoscopy was performed and an 1 cm tear was repaired with suturing. Patient tolerated the procedure well and discharged 2 days post op. Event was related to retroflexion. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever | Gastrointestinal disorders | Non-systematic Assessment | Severity was Mild and resolved in 1 day. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Operations | Motus GI | 954-541-8000 | anniec@motusgi.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 30, 2019 | Sep 14, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 94 |
| 1 |
| 94 |
| 3 |
| 94 |
|
|
| abdominal pain | Gastrointestinal disorders | Non-systematic Assessment | Severity was Mild and resolved in 1 day. |
|
| Drop in Hemoglobin | Gastrointestinal disorders | Non-systematic Assessment | Severity was Mild and resolved in 2 day. |
|
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |