A novel device for intracolonoscopy cleansing of inadequately prepared colonoscopy patients: a feasibility study

Keulen, Kelly E. van; Neumann, Helmut; Schattenberg, Jörn M.; Esch, Aura A. J. van; Kievit, Wietske; Spaander, Manon C.W.; Siersema, Peter D.

doi:10.1055/a-0632-1927

Cited by 19 publications

(23 citation statements)

References 30 publications

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“…A feasibility study including 47 outpatients at 3 clinical sites who were prescribed a minimal preparation of 20 mg Bisacodyl reported high rates of cecal intubation (97.9%), significant improvement in Boston Bowel Preparation Score (BBPS) scores (from a median score of 3.0 pre Pure-Vu to 9.0 post Pure-Vu cleansing), and high rates of physician satisfaction regarding system usability [ 8 ]. An additional study of 50 outpatients who were prescribed a minimal preparation of 20 mg Bisacodyl showed that Pure-Vu significantly increased BBPS scores and increased the proportion of patients with an adequate cleansing level (31% of patients at baseline to 98% post Pure-Vu cleansing; p < 0.001) [ 9 ].…”

Section: Introductionmentioning

confidence: 99%

“…The System generates a mixture of water and air that creates a high intensity pulsed vortex that is delivered through four irrigation jets to break up fecal content. The fecal matter and fluids are simultaneously removed through two suction ports in the Oversleeve and delivered into external waste receptacles [7][8][9]. The Pure-Vu Workstation which is a control and pump system also has the ability to sense the buildup of material in the suction ports and automatically purge the ports to avoid clogging thus allowing significant debris to be removed from the colon.…”

Section: Introductionmentioning

confidence: 99%

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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

et al. 2021

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Background High quality bowel preparation prior to colonoscopy can be difficult to achieve in the inpatient setting. Hospitalized patients are at risk for extended hospital stays and low diagnostic yield due to inadequate bowel preparation. The Pure-Vu System is a novel device intended to fit over existing colonoscopes to improve intra-colonoscopy bowel preparation. The objective of the REDUCE study was to conduct the first inpatient study to evaluate optimization of bowel preparation quality following overnight preparation when using the Pure-Vu System during colonoscopy. Methods This multicenter, prospective feasibility study enrolled hospitalized subjects undergoing colonoscopy. Subjects recorded the clarity of their last bowel movement using a 5-point scale prior to colonoscopy. After one night of preparation, all enrolled subjects underwent colonoscopy utilizing the Pure-Vu System. The primary endpoint was improvement of colon cleanliness from baseline to post-cleansing with the Pure-Vu System as assessed by the improvement in Boston Bowel Preparation Scale (BBPS). An exploratory analysis was conducted to assess whether the clarity of the last bowel movement could predict inadequate bowel preparation. Results Ninety-four subjects were included. BBPS analyses showed significant improvements in bowel preparation quality across all evaluable colon segments after cleansing with Pure-Vu, including left colon (1.74 vs 2.89; p < 0.0001), transverse colon (1.74 vs 2.91; p < 0.0001), and the right colon (1.41 vs 2.88; p < 0.0001). Prior to Pure-Vu, adequate cleansing (BBPS scores of ≥ 2) were reported in 60%, 62%, and 47% for the left colon, transverse colon, and right colon segments, respectively. After intra-colonoscopy cleansing with the Pure-Vu System, adequate colon preparation was reported in 100%, 99%, and 97% of the left colon, transverse colon, and right colon segments, respectively. Subjects with lower bowel movement clarity scores were more likely to have inadequate bowel preparation prior to cleansing with Pure-Vu. Conclusions In this feasibility study, the Pure-Vu System appears to be effective in significantly improving bowel preparation quality in hospitalized subjects undergoing colonoscopy. Clarity of last bowel movement may be useful indicator in predicting poor bowel preparation. Larger studies powered to evaluate clinical outcomes, hospital costs, and blinded BBPS assessments are required to evaluate the significance of these findings. Trial registration Evaluation of the Bowel Cleansing in Hospitalized Patients Using Pure-Vu System (NCT03503162).

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

et al. 2021

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“…For patients with early stage CRC, 23 It was further assumed that PureVu was used only in the 25% of patients who presented with inadequately prepped colons [24] in each of the above groups at an additional cost to the procedure in using PureVu of $750 [25]. Based on a systematic review of the literature which demonstrated a 2-2.1% inadequate bowel prep with PureVu [18,19] and; to be conservative, the assumption was made in the Markov model that in 5% of all cases in which PureVu was used, inadequate bowel prep occurred.…”

Section: Methodsmentioning

confidence: 99%

“…It delivers a pulsed irrigation of water and air that breaks up fecal matter and evacuates the content in inadequately prepped colons. Results from peer reviewed articles have demonstrated in inadequately prepped colons that PureVu was able to properly clean 95% of colons allowing for an adequate colonoscopy to be performed [18,19]. The purpose of this study is to examine PureVu examine in a Markov lifetime cost-effectiveness analysis comparing the use of PureVu to standard of care (SOC) for patients undergoing an outpatient colonoscopy in the United States.…”

Section: Introductionmentioning

confidence: 99%

Colonoscopy in poorly prepped colons: a cost effectiveness analysis comparing standard of care to a new cleansing technology

Voigt¹,

Mosier

Gralnek

2021

Cost Eff Resour Alloc

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Background The objective of this Markov model lifetime cost-effectiveness analysis was to evaluate a new medical device technology which minimizes redo colonoscopies on the outcomes of cost, quality of life, and aversion of colorectal cancers (CRC). Methods A new technology (PureVu® System) which cleans inadequately prepped colons was evaluated using TreeAge 2019 software in patients who presented with inadequate prep in outpatient settings in the US. PureVu was compared to the standard of care (SOC). Peer reviewed literature was used to identify the CRC incidence cancers based on missing polyps. Costs for procedures were derived from 2019 Medicare and from estimated private payer reimbursements. Base case costs, sensitivity analysis and incremental cost effectiveness (ICE) were evaluated. The cost of PureVu was $750. Results Assuming a national average compliance rate of 60% for colonoscopy, the use of PureVu saved the healthcare system $833–$992/patient depending upon the insurer when compared to SOC. QALYs were also improved with PureVu mainly due to a lower incidence of CRCs. In sensitivity analysis, SOC becomes less expensive than PureVu when compliance to screening for CRC using colonoscopy is ≤ 28%. Also, in order for SOC to be less expensive than PureVu, the list price of PureVu would need to exceed $1753. In incremental cost effectiveness analysis, PureVu dominated SOC. Conclusion Using the PureVu System to improve bowel prep can save the healthcare system $3.1–$3.7 billion per year, while ensuring a similar quality of life and reducing the incidence of CRCs.

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“…In another system called ColonoScoPrep® the colon is prepared by the infusion of warm water before colonoscopy. All of them have been reported to be safe and to improve the quality of bowel preparation, though RCTs are lacking (58–63). More evidence is thus needed to recommend them in clinical practice.…”

Section: Management Of Patients At Risk Of Inadequate Bowel Preparationmentioning

confidence: 99%

Strategies to Improve Inadequate Bowel Preparation for Colonoscopy

2019

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Bowel cleansing is one of the most important parameters included in the evaluation of colonoscopy quality. The available evidence suggests that inadequate bowel preparation reduces the diagnostic yield of colorectal neoplasia and increases post-colonoscopy colorectal cancer risk. Nowadays, up to 30% of patients referred for colonoscopy have a poor bowel cleansing. Recently, several studies have analyzed the risk factors for inadequate bowel cleansing as well as the strategies to optimize bowel preparation. In this review, we have focused on summarizing the available evidence in this field.

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A novel device for intracolonoscopy cleansing of inadequately prepared colonoscopy patients: a feasibility study

Abstract: This feasibility study suggests that the intraprocedural cleaning device appears to be safe and effective in cleaning poorly prepared colons to an adequate level, allowing a thorough colorectal examination.

Cited by 19 publications

References 30 publications

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

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

Colonoscopy in poorly prepped colons: a cost effectiveness analysis comparing standard of care to a new cleansing technology

Strategies to Improve Inadequate Bowel Preparation for Colonoscopy

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