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Saneso colonoscope is a novel FDA cleared colonoscope that provides a 360 degree integrated view of the colon. Saneso colonoscope has five cameras and multiple LED lights at the distal head. The objective of the present study is to evaluate clinical success of the Saneso colonoscope in intubation of the terminal ileum and to obtain user feedback with regards to usability characteristics compared to predicate devices.
This study is a prospective, multi-center case series of per standard of care colonoscopy procedures using a nonsignificant risk Saneso 360 degree colonoscope. 40 cases were included at 3 clinical sites. Patients who meet all eligibility criteria were included and had a clinically indicated colonoscopy procedure performed using the study device. Immediately thereafter, patients had a colonoscopy procedure using standard colonoscope (Olympus CF 180) by a second endoscopist. Enrolled subjects were followed for 7 days after their procedure. If the procedure was not successful with the study device, the endoscopist completed the procedure with a traditional colonoscope used at each facility. This study was approved by the institutional review board of respective sites. The clinical trial was conducted in accordance with the standards of Good Clinical Practice (GCP) and in accordance with the principles of the Declaration of Helsinki.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Arm Study device | Experimental | Patients who meet all eligibility criteria were included and had a clinically indicated colonoscopy procedure performed using the study device. Immediately thereafter, patients had a colonoscopy procedure using standard colonoscope (Olympus CF 180) by a second endoscopist. |
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| Study Arm - Predicate Device | Active Comparator | Patients who meet all eligibility criteria were included and had a clinically indicated colonoscopy procedure performed using the study device. Immediately thereafter, patients had a colonoscopy procedure using standard colonoscope (Olympus CF 180) by a second endoscopist. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colonoscopy | Device | Patients who meet all eligibility criteria were included and had a clinically indicated colonoscopy procedure performed using the study device. Immediately thereafter, patients had a colonoscopy procedure using standard colonoscope (Olympus CF 180) by a second endoscopist. |
| Measure | Description | Time Frame |
|---|---|---|
| Intubation of terminal ileum and cecum | Intubation of the terminal ileum and cecum | 4 months. |
| Measure | Description | Time Frame |
|---|---|---|
| User feedback for operating characteristics of the device | User feedback for operating characteristics of the device | 4 months. |
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Inclusion Criteria:
Scheduled for a clinically indicated routine colonoscopy procedure ASA class 1-3.
Exclusion Criteria:
Patients who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor ASA class 4-5.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valley Endoscopy Center | Saint Clairsville | Ohio | 43950 | United States | ||
| Wintersville Endoscopy Center, Wintersville |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D003113 | Colonoscopy |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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The objective of the present study is to Study the clinical success and clinical safety of the Saneso colonoscope
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| Wintersville |
| Ohio |
| 43953 |
| United States |
| West Virginia University School of Medicine - Davis Medical Center | Elkins | West Virginia | 26241 | United States |
| West Virginia University School of Medicine - Reynolds Memorial Hospital | Glendale | West Virginia | 26038 | United States |
| West Virginia University School of Medicine - Reynolds Memorial Hospital, | Glendale | West Virginia | 26506 | United States |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |