Clinical trial · Interventional
Evaluation of the Bowel Cleansing in Hospitalized Patients Using Pure-Vu System
NCT03503162CI-TRIAL-00051241completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Gastrointestinal Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pure-Vu System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Colonoscopy with Pure-Vu System
- description
- Standard colonoscopy procedure with Pure-Vu System
- interventionNames
- Device: Pure-Vu System
Primary outcomes (1)
- measure
- The Rate of Adequate Cleansing Level Before and After the Use of the Pure-Vu System
- timeFrame
- up to 2 hours
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 22 Years
Show eligibility criteria text
Inclusion Criteria: 1. Hospitalized patients who are indicated for a screening, diagnostic, surveillance or therapeutic colonoscopy 2. Patients' age \> 22 years 3. Patient has signed the informed consent Exclusion Criteria: 1. Patients with known Inflammatory Bowel Disease and / or active Colitis 2. Patients with active diverticulitis 3. Patients with known or detected (during colonoscopy) bowel obstruction 4. Patients with BMI ≤ 18 5. Patients with ascites Child Pugh C 6. Patients who are 30 days post-transplant 7. Patients treated with Peritoneal dialysis 8. Patients under active IV inotropic medications 9. Patients with LVAD 10. Patients who have active anticoagulant medications (excluding aspirin) or dual antiplatelet therapy in their system prior to the procedure. (Note: to avoid exclusion therapy should be discontinued 48 hours or greater prior to the procedure based on discretion of physician) 11. Subjects with known coagulation disorder (INR ≥ 2 or platelets \<50,000) 12. Subjects with hemodynamic instability. 13. Pregnancy (as stated by patient) or breast feeding 14. Subjects with altered mental status/inability to provide informed consent 15. Patients who have participated in another interventional clinical study in the last 2 months
References
Publications (1)
- DERIVEDNeumann 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. PMID 34022813