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JOURNAL ONKOLOGIE – STUDIE

A Study to Evaluate the Safety and Efficacy of the Use of ME-APDS During Colonoscopy

Rekrutierend

NCT-Nummer:
NCT04640792

Studienbeginn:
Oktober 2020

Letztes Update:
09.02.2021

Wirkstoff:
-

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Magentiq Eye LTD

Collaborator:
-

Studienleiter

Harold Jacob, MD
Principal Investigator
Hadassah Medical Organization

Kontakt

Studienlocations
(3 von 6)

Alle anzeigen

Studien-Informationen

Detailed Description:

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.

Ein-/Ausschlusskriterien

Inclusion Criteria:

1. Able to provide written informed consent prior to any study procedures;

2. Able to communicate clearly with the Investigators and study staff;

3. Males and females aged between 18 - 90 years of age;

4. Referred and Scheduled for either screening or surveillance colonoscopy which is

scheduled every 3 to 10 years;

5. Has not been referred to the test after positive iFOBT.

Exclusion Criteria:

1. Has a known or suspected colorectal tumor or polyp on referral;

2. Has a referral for therapeutic procedure (i.e. endoscopic mucosal resection,

intervention to stop a lower gastro-intestinal bleeding, etc.);

3. Has not corrected anticoagulation disorders;

4. Inability to provide informed consent;

5. Has any clinically significant condition that would, in the opinion of the

investigator, preclude study participation;

6. Unable or unwilling, in the opinion of the Investigator to comply with the

requirements of the protocol;

7. Employees of the investigator and study site or the sponsor, as well as family members

of the employees or the investigator or the sponsor;

8. Has inadequate bowel preparation, defined as: Boston Bowel Preparation Score (BBPS) <6

or any segment <2 (each procedure report will include the BBPS);

9. Any woman who is pregnant or potentially pregnant.

Studien-Rationale

Primary outcome:

1. 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)

2. 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

Secondary outcome:

1. 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

2. 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

Studien-Arme

  • 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)

Geprüfte Regime

  • 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

Quelle: ClinicalTrials.gov


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