A Study to Evaluate the Safety and Efficacy of the Use of ME-APDS During Colonoscopy
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|ClinicalTrials.gov Identifier: NCT04640792|
Recruitment Status : Recruiting
First Posted : November 23, 2020
Last Update Posted : February 9, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Screening Colonoscopy Surveillance Colonoscopy||Procedure: Screening or Surveillance Conventionall colonoscopy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||952 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Two Arm Multi-Center Study to Evaluate the Safety and Efficacy of the Use of Magentiq Eye's Automatic Polyp Detection System (ME-APDS) During Colonoscopy|
|Actual Study Start Date :||October 1, 2020|
|Estimated Primary Completion Date :||September 30, 2021|
|Estimated Study Completion Date :||September 30, 2021|
No Intervention: Common Colonoscopy (Group A)
Patients will be examined with Conventional Colonoscopy (CC)
Experimental: Magentiq Eye Assisted Colonoscopy (Group B)
Patients will be examined with Magentiq Eye Assisted Colonoscopy (MEAC)
Procedure: Screening or Surveillance Conventionall colonoscopy
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
- Comparison of the Adenoma Per Colonoscopy (APC) between the two arms [ Time Frame: During the Colonoscopy Procedure ]Compare the APC of the Magentiq Eye Assisted Colonoscopy (MEAC) with the Conventional Colonoscopy (CC)
- Comparison of the Adenoma Per Extraction (APE) between the two arms [ Time Frame: During the Colonoscopy Procedure ]Compare the APE of the MEAC with the CC
- Comparison of the Adenoma Miss Rate (AMR) between the two arms [ Time Frame: During the Colonoscopy Procedure ]Compare the AMR of the MEAC with the CC
- Comparison of the Adenoma Detection Rate (ADR) between the two arms [ Time Frame: During the Colonoscopy Procedure ]Compare the ADR of the MEAC with the CC
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04640792
|Contact: Dror Zur, Ph.D.||+email@example.com|
|Contact: Helena Grinberg, Ph.D.||+firstname.lastname@example.org|
|United States, New York|
|Columbia University Irving Medical Center||Not yet recruiting|
|New York, New York, United States, 10032|
|Contact: Benjamin Lebwohl, Prof.|
|United States, Ohio|
|MetroHealth System||Not yet recruiting|
|Cleveland, Ohio, United States, 44109|
|Contact: Marc Landsman, MD|
|United States, Tennessee|
|Erlanger Health System||Recruiting|
|Chattanooga, Tennessee, United States, 37403|
|Contact: Arslan Kahloon, MD|
|Principal Investigator: Arslan Kahloon, MD|
|GastroZentrum Lippe||Not yet recruiting|
|Bad Salzuflen, Germany, 32105|
|Contact: Helmut Neumann, MD|
|Department of Gastroenterology, Shamir Medical Center, Israel||Recruiting|
|Be'er Ya'aqov, Israel|
|Contact: Haim Shirin, Prof|
|Hadassah Medical Organization||Recruiting|
|Jerusalem, Israel, 91120|
|Contact: Harold Jacob, MD|
|Principal Investigator:||Harold Jacob, MD||Hadassah Medical Organization|