Clinical trial · Interventional
First in Man Aer-O-Scope
A Single-center Study to Evaluate the Safety & Performance of the Aer-O-Scope for Traveling Through the Colon in Healthy Volunteers
NCT02102412CI-TRIAL-00028869terminatedPhase 1ClinicalTrials.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): Changes made to device.
Summary
Brief summary (as posted)
A single center study intended to evaluate the Aer-O-Scope Colonoscope System.
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 |
|---|---|---|---|
| Screening Colonoscopy for Low Risk Subjects | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| screening colonoscopy | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- single arm
- description
- single arm patients underwent colonoscopy with aer-o-scope followed by conventional colonoscopy to assess if any mucosal damage occurred with the experimental device.
- interventionNames
- Biological: screening colonoscopy
Primary outcomes (1)
- measure
- Ability to traverse the colon using the aer-o-scope
- timeFrame
- under 60 minutes
- description
- a propulsion system using low pressure co2 gas and balloons is used to propel the system through the colon
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Healthy volunteers between 18 and 65 years of age. * Sign informed consent. Exclusion Criteria: * Subjects with any known GI related symptoms complaints or GI diseases. * Subjects with cancer or other life threatening diseases or conditions. * Pregnant women. * Subjects who underwent any abdominal surgery. * Morbid Obesity (BMI \> 40). * Drug abuse or alcoholism. * Bed-ridden subject. * Inadequate communication with the subject. * Subjects under custodial care. * Participation in any clinical study within the last 30 days. * Subjects with known cardiovascular and pulmonary diseases.
References
Publications (0)
Data not yet available
No reference posted for this study.