Clinical trial · Interventional
Clinical Study-evaluate Performance&Safety "Aer-O-Scope" in Colon of Low Risk Patients
A Clinical Study to Evaluate the Performance & Safety of the "Aer-O-Scope" Traveling Through the Colon in Low Risk Subjects
NCT00867724CI-TRIAL-00028884completedN/AClinicalTrials.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)
A double center study to evaluate the safety and efficacy of the Aer-O-Scope in traveling through the colon in low risk subjects.
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 |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aer-O-Scope Colonoscopy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Aer-O-Scope Colonoscopy
- description
- Screening Colonoscopy
- interventionNames
- Device: Aer-O-Scope Colonoscopy
Primary outcomes (1)
- measure
- Ability to screen the entire length of the colon to the cecum.
- timeFrame
- 30 -60 minutes
Secondary outcomes (1)
- measure
- Safety endpoints to include incidence of bowel perforation, Colonic bleeding, Damage to colon, rectum and anus mucosa or any other Adverse events
- timeFrame
- 24 hours
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female patients between 18 and 70 years of age * Patients who are generally healthy and classified as low risk for CRC * Patients who are ready to undergo standard colonoscopy examination including colon prep. * Signed informed consent Exclusion Criteria: * Patients with any known GI related symptoms complaints or GI diseases * Patients with cancer or other life threatening diseases or conditions * Patients with unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal' gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise patient safety. Patients with a known history of blood clotting problems and /or who are on anti-coagulant therapy and cannot stop treatment for the purpose of this study. (Patients taking up to 100mg aspirin for prophylactic treatment are acceptable for this study). * Pregnant women * Patients who underwent abdominal surgery that is deemed by the investigator to effect the procedure * Morbid Obesity (BMI \> 40) * Drug abuse or alcoholism * Bed-ridden patient * Inadequate communication with the patient * Patients under custodial care * Participation in current clinical study or clinical study within 30 days prior to the procedure
References
Publications (0)
Data not yet available
No reference posted for this study.