In clinical studies, the Pure-Vu® System was demonstrated to be safe and effective in cleaning inadequately prepared colons to an adequate level for a thorough exam.
Adequate bowel preparation rate improved from 38% to 96% following use of Pure-Vu® System
The REDUCE study was a multi-center inpatient prospective trial designed to evaluate Pure-Vu® System’s ability to consistently and reliably improve bowel preparation to facilitate a successful colonoscopy in a timely manner in patients who were indicated for a diagnostic colonoscopy. The study enrolled 95 hospitalized patients1 on schedule regardless of their level of pre-procedural bowel preparation. The analysis from the REDUCE study showed statistically significant improvement in each colon segment after Pure-Vu® System use. The per segment BBPS improved from an average baseline of 1.74, 1.74 and 1.5 to 2.89, 2.91 and 2.86, respectively, with a statistically significant p value of .001 for all three segments of the colon. Inpatients that received Pure-Vu® System, adequate bowel preparation improved from a baseline of 38% to 96% in segments evaluated.
1: One patient was excluded due to the discovery of ulcerative colitis during procedure which was a study exclusion
Multicenter Study 1 and 2
Patients were given a pre-procedural preparation consisting of only an 18-24 hour liquid diet and 4 bisacodyl/laxadin tablets (Dulcolax) to purposely create inadequately prepped colons. No traditional purgative was given. The Pure-Vu® System significantly increased the number of subjects with an adequate cleansing level (BBPS ≥ 2 in each colon segment) from 31% at baseline to 98% after use of the Pure-Vu® System (p<0.001). Physicians were satisfied with the device's general ease of use. No major difficulties were experienced when performing polypectomy. No serious adverse events were reported.
Multicenter Study 3
Patients were randomized to receive one of two minimal bowel preparations: three doses of 17gr MiraLAX each mixed in 8.5 oz of clear liquids or two doses of 7.5oz Magnesium Citrate (MgC) each taken with 19.5oz of clear liquid. A study amendment early on replaced the MiraLAX arm, due to obvious inferior Boston Bowel Preparation Scale (“BBPS”), a validated assessment instrument, scoring from the outset. The replacement arm consisted of two doses of 5oz MgC taken with 16oz of clear liquid. All patients were allowed to eat a low residue diet (consisting of chicken, pasta, eggs, etc.) on the day prior and were asked to avoid seeds and nuts for five days prior to their procedure. Study objectives evaluated for each study arm included: (1) improvement of colon cleansing from presentation baseline to completion of the procedure (as assessed by the BBPS) through the use of the Pure-Vu® System, (2) time required to reach the cecum, (3) total procedure time, and (4) safety. No significant differences were found between the three groups with regard to demographics or indication for colonoscopy. No serious adverse events related to the device were reported. The use of the Pure-Vu® System enabled successful intraprocedural cleansing of the colon and ensured successful completion of all colonoscopies performed (100% success rate). Patients in the study had an average baseline BBPS of 3.67±2.86 which was improved to an average of 8.91±0.35 (p value <0.0001) following use of the Pure-Vu® System. The Pure-Vu® System was found to be safe, efficacious, and easy to use in cleansing inadequately prepared colons, enabling the endoscopist to conduct a complete examination. The use of the Pure-Vu® System added some time to the procedure, but the total procedure time was approximately 25 minutes in this study.