Clinical trial · Interventional
Optimizing the Preparation Regime Prior to Colonoscopy Procedure With Pure-Vu System
NCT03493009CI-TRIAL-00035568withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Difficulties to sign a contract with the hospital, due to logistic changes in the hospital.
Summary
Brief summary (as posted)
The primary objective of this multicenter, prospective, randomized study is to evaluate the performance of Pure-Vu System in cleansing patients' colon who are indicated for a colonoscopy procedure using one of two different reduce bowel preparation regimes.in addition, the cecum intubation rate, time to cecum, total procedure time, and adverse event will be evaluated.
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 Diseases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pure-Vu System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 10mg Magnesium citrate
- description
- subjects will be required to follow a specific bowel preparation instruction consisting of dietary restrictions (no dried fruit, seeds or nuts) starting 5 days prior to the colonoscopy, an low residue diet at the day before the procedure, followed by a split dose of 10 mg of Magnesium citrate, followed by colonoscopy procedure with Pure-Vu System
- interventionNames
- Device: Pure-Vu System
- type
- EXPERIMENTAL
- label
- 15mg Magnesium citrate
- description
- subjects will be required to follow a specific bowel preparation instruction consisting of dietary restrictions (no dried fruit, seeds or nuts) starting 5 days prior to the colonoscopy, an low residue diet at the day before the procedure, followed by a split dose of 15 mg of Magnesium citrate, followed by colonoscopy procedure with Pure-Vu System
- interventionNames
- Device: Pure-Vu System
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 22 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subjects scheduled for colonoscopy procedure 2. Subjects in the age range of 22-75 years inclusive 3. Subject is willing and able to participate in the study procedures and to understand and sign the informed consent. Exclusion Criteria: 1. Patients with active Inflammatory Bowel Disease 2. Patients with known diverticulitis disease or with prior incomplete colonoscopy due to diverticular disease 3. Patients with known bowel obstruction 4. Patient with chronic constipation 5. History of prior surgery to colon and/or rectum 6. ASA (Physical status classification system) ≥ III 7. Renal insufficiency (Creatinine ≥ 1.5mg /dL) (based on medical history) 8. Abnormal Liver enzymes (ALT/AST ≥ 2 times upper limits of normal) (based on medical history) 9. Patients taking anticoagulants drugs (excluding aspirin) or dual antiplatelet therapy 10. Patients with known coagulation disorder (INR \>1.5). 11. Pregnancy (as stated by patient) or breast feeding 12. Patients with altered mental status/inability to provide informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.