Clinical trial · Interventional
ProtectiScope CS Intended for Diagnostic and Therapeutic Colonoscopy
Evaluation of Safety and Efficacy of a New Colonoscope, ProtectiScope CS, to Diagnose Large Bowel Diseases
NCT00715325CI-TRIAL-00001687unknownPhase 1 / Phase 2ClinicalTrials.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 purpose of this study is to determine whether the ProtectiScope CS is capable to perform diagnostic and therapeutic colonoscopy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Protectiscop CS | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Device: Protectiscop CS
Primary outcomes (1)
- measure
- To determine the success rate in reaching within working distance of the Cecum with no complications.
- timeFrame
- 1 month
Secondary outcomes (1)
- measure
- To assess the ability to perform routine therapeutic interventions such as biopsies, polypectomies, APC etc. as compared to therapeutic interventions with standard colonoscopes found in the literature.
- timeFrame
- 1 month
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Subject between the ages of 18 and 80 * Subject is indicated for screening colonoscopy * Subject is willing to sign informed consent form Exclusion Criteria: * Subject is suspected, based on radiographic or other clinical grounds, of suffering from one or more of the following: full or partial colonic obstruction; acute abdomen; gross hematochezia; severely ulcerated colon; diverticulitis; severe diverticulosis; toxic megacolon. * Subject has active cardiac problems and history of heart failure, severe pulmonary diseases renal failure (creatinine \>2) uncontrolled diabetes and any other illness judged by investigator to substantiate exclusion. * Subject has a history of significant other diseases. * Subject has a history of psychiatric disorders which would prevent compliance with study instructions * For female subjects, suspicion of pregnancy * Subject has received treatment with another investigational drug or device within the past 30 days
References
Publications (0)
Data not yet available
No reference posted for this study.