Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The PeerScope System consists of Peer Medical camera heads, endoscopes, video system, light source and other ancillary equipment. The system is intended for endoscopic diagnosis, treatment and video observation of the digestive tract. The PeerScope system model B is indicated for use for endoscopy and endoscopic treatment within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) of adults patients.
Objective:To compare the additional diagnostic yield obtained by using the PeerScope Systemâ„¢ extended view vs. the diagnostic yield obtained by the Standard view colonoscopy.
In addition, time measurements including time to cecum, time for withdrawal and overall procedure time will be analyzed and reported for each group.
Design:
Patients who are scheduled for screening, surveillance or diagnostic colonoscopy will be recruited to the study and randomized to one of two groups. Each enrolled subject will undergo two "back-to-back" procedures.
Subjects in Group A (study group) will undergo a Standard view colonoscopy followed immediately by a PeerScope Systemâ„¢ extended view colonoscopy. Subjects in Group B (control group) will undergo a PeerScope Systemâ„¢ extended view colonoscopy followed immediately by a Standard view colonoscopy.
Results from the two groups will be analyzed and compared, with primary outcome measures being detection rates for total polyps and detection rates for adenomas. Secondary outcome measures will include withdrawal time, total procedure time and characteristics of polyps detected, including size and histological results.
Subjects will be followed through a 24 hour and a 7 days telephone interview for analysis of unexpected adverse events. Clinical results will be analyzed using various statistical measures of significance.
Study Design:
Multi-center study with up to 196 patients. No. of Patients:
Up to 196 treated patients will be enrolled into the study. Primary Performance Endpoint:
Safety Analysis:
Incidence of device-related and procedure-related serious adverse events. Incidence of complications using PeerScope Systemâ„¢
Known complications include:
Secondary Endpoints / Other Outcomes:
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (study group) | Active Comparator | Subjects in Group A (study group) will undergo a Standard view colonoscopy followed immediately by a PeerScope Systemâ„¢ extended view colonoscopy. |
|
| Group B (control group) | Active Comparator | Group B (control group) will undergo a PeerScope Systemâ„¢ extended view colonoscopy followed immediately by a Standard view colonoscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colonoscopy done with:PeerMedical System and Olympus/Pentax/Fuji colonoscopy system | Device | endoscopic diagnosis, treatment and video observation of the digestive tract, endoscopy and endoscopic treatment within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) of adults patients |
| Measure | Description | Time Frame |
|---|---|---|
| polyp detection rate | Sample size calculation is based on detecting a difference in the adenoma overall detection rate and the overall polyp detection rate using the PeerScope Systemâ„¢ extended view as compared to Standard view colonoscopy. Total sample size will be 196 patients. Each patient will undergo the procedure by the two devices: PeerScope Systemâ„¢ extended view and Standard view colonoscopy. The rational for this sample size is based on detecting a rate difference of 20% between the study devices. | 1 year |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ian Gralnek, Prof. | Rambam Health Care Campus | Principal Investigator |
| Peter Siersema, Prof. | UMC Utrecht | Principal Investigator |
| Erwin Santo, Prof. | The Tel Aviv Sourasky Medical Center | Principal Investigator |
| Ori Segol, Dr. | Carmel Medical Center | Principal Investigator |
| Alan Sloyer, Dr. | North Shore Gastroenterology Associates, P.C. | Principal Investigator |
| Jay S. Fenster, Dr. | Southshore Gasstroenterology, P.C | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Shore Gasstroenterology Assoiates, P.C. | New York | New York | United States | |||
| Southshore Gasstroenterology, P.C |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24560453 | Derived | Gralnek IM, Siersema PD, Halpern Z, Segol O, Melhem A, Suissa A, Santo E, Sloyer A, Fenster J, Moons LM, Dik VK, D'Agostino RB Jr, Rex DK. Standard forward-viewing colonoscopy versus full-spectrum endoscopy: an international, multicentre, randomised, tandem colonoscopy trial. Lancet Oncol. 2014 Mar;15(3):353-60. doi: 10.1016/S1470-2045(14)70020-8. Epub 2014 Feb 20. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| D000236 | Adenoma |
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D003113 | Colonoscopy |
| D008403 | Mass Screening |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| New York |
| New York |
| United States |
| Carmel Medical Center | Haifa | Israel |
| Elisha Medical Center | Haifa | Israel |
| The Tel Aviv Sourasky Medical Center | Tel Aviv | Israel |
| UMC | Utrecht | Netherlands |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| 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 |
| D006306 | Health Surveys |
| D011795 | Surveys and Questionnaires |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D015980 | Public Health Practice |