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ME-APDS is a device (software-based with hardware) developed by Magentiq Eye LTD and intended to support the decision of the endoscopist on polyps which appear in the colonoscopy video during the colonoscopy procedure.
This randomized two arm colonoscopy trial will mainly compare APC and APE between Magentiq Eye Assisted Colonoscopy (MEAC) and Conventional Colonoscopy (CC) in patients referred for either screening or surveillance colonoscopies.
The primary objective of the present study is to compare the number of Adenomas Per Colonoscopy (APC) and the Adenomas Per Extraction (APE) between the Magentiq Eye-Assisted Colonoscopy (MEAC) and Conventional Colonoscopy (CC). These are also the co-primary endpoints.
The secondary endpoints are Adenoma Miss Rate (AMR, tested on part of the total study population) and Adenoma Detection Rate (ADR).
This study mainly hypothesizes that more adenomas will be detected in MEAC compared to CC (higher APC in MEAC compared to CC), and that the reduction of APE in MEAC compared to CC (if there will be a reduction) will be limited.
The study also assumes that AMR will be reduced in MEAC compared to CC and that ADR will increase to some level in MEAC compared to CC.
The study will include 952 subjects . Eligible patients will be randomized in a 1:1 ratio into two groups, group A and B. In group A, patients will be examined with CC. Patients in group B will be examined using MEAC. Immediately after the randomization, a sub-randomization will be performed on whether an immediate second examination (for AMR calculation) will be conducted or not (136 patients will undergo second examination).
The colonoscopy will be performed in accordance with the standard of care of each medical center in either MEAC or CC.
After the colonoscopy procedure patients will be observed at the endoscopy unit until the discharge criteria are met as per the standard clinical protocol of the medical center. After here, they will be discharged by the treating physician.
Study follow-up period will be up to 30-days post-colonoscopy to register (serious) adverse events and it will be in accordance with the standard of care of medical center.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Common Colonoscopy (Group A) | No Intervention | Patients will be examined with Conventional Colonoscopy (CC) | |
| Magentiq Eye Assisted Colonoscopy (Group B) | Experimental | Patients will be examined with Magentiq Eye Assisted Colonoscopy (MEAC) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Screening or Surveillance Conventionall colonoscopy | Procedure | Patients in Group A (CC) will undergo Screening or Surveillance Conventual Colonoscopy, Patients in Group B (MEAC) will undergo Screening or Surveillance Colonoscopy with ME-ADPS Device |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the Adenoma Per Colonoscopy (APC) between the two arms | Compare the APC of the Magentiq Eye Assisted Colonoscopy (MEAC) with the Conventional Colonoscopy (CC) | During the Colonoscopy Procedure |
| Comparison of the Adenoma Per Extraction (APE) between the two arms | Compare the APE of the MEAC with the CC | During the Colonoscopy Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the Adenoma Miss Rate (AMR) between the two arms | Compare the AMR of the MEAC with the CC | During the Colonoscopy Procedure |
| Comparison of the Adenoma Detection Rate (ADR) between the two arms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Siersema, MD, Ph.D. | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21202 | United States | ||
| Columbia University Irving Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38395537 | Derived | Maas MHJ, Neumann H, Shirin H, Katz LH, Benson AA, Kahloon A, Soons E, Hazzan R, Landsman MJ, Lebwohl B, Lewis SK, Sivanathan V, Ngamruengphong S, Jacob H, Siersema PD. A computer-aided polyp detection system in screening and surveillance colonoscopy: an international, multicentre, randomised, tandem trial. Lancet Digit Health. 2024 Mar;6(3):e157-e165. doi: 10.1016/S2589-7500(23)00242-X. |
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Compare the ADR of the MEAC with the CC
| During the Colonoscopy Procedure |
| New York |
| New York |
| 10032 |
| United States |
| MetroHealth System | Cleveland | Ohio | 44109 | United States |
| Erlanger Health System | Chattanooga | Tennessee | 37403 | United States |
| GastroZentrum Lippe | Bad Salzuflen | 32105 | Germany |
| Mainz University Medical Center | Mainz | Germany |
| Assuta | Haifa | Select State | Israel |
| Department of Gastroenterology, Shamir Medical Center, Israel | Be’er Ya‘aqov | Israel |
| Shamir Medical Center | Be’er Ya‘aqov | Israel |
| Hadassah Medical Organization | Jerusalem | 91120 | Israel |
| The Radboud University Medical Center | Nijmegen | Netherlands |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D008403 | Mass Screening |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| 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 |
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