Adenoma Detection Rate With Endocuff-Assisted Colonoscopy - an Italian Trial

NCT03612674 | Unknown

• 1 other identifier: F17G18000000007
• Study Type: interventional
• Target: 2,100
• Locations: 1 country
• Sites: 12

Brief Summary

In European countries, colorectal cancer (CRC) represents an important public health problem. It is widely held view that most carcinomas develop from an adenoma-carcinoma progression. Adenoma detection rate (ADR) is a marker of high quality colonoscopy and it was inversely associated with the risk of interval colorectal cancer, advanced-stage interval cancer, and fatal interval cancer after colonoscopy. Although colonoscopy is considered the gold standard for adenoma detection, it has shown some limits, so industry has aimed at increasing detection rate of adenomas providing new technologies, most of witch to detect lesions located in blind spots. ARC Endocuff Vision (AEV), the second generation of Endocuff, represents a new generation of these devices, thus assessing the diagnostic sensibility of ARC Endocuff Vision assisted colonoscopy (EAC) is an interesting challenge. Aim of the study is to compare ADR of EAC versus standard colonoscopy among FIT positive subjects in the context of CRC screening programs.

Conditions

Colorectal Cancer; Colorectal Adenoma; Colorectal Polyp; Colorectal Neoplasms

Keywords

Mass screening; Adenoma detection rate; ARC Endocuff Vision; Colonoscopy

Outcome Measures

Primary Outcomes (1)

• Adenoma Detection Rate (ADR)

  Comparison of the number of adenomas (ADR) detected per subject between the Endocuff Vision colonoscopy and the standard colonoscopy.

  Through study completion, an average of 1 year

Secondary Outcomes (11)

• Patient values

  Day 1

• Exam values

  Day 1

• Number of lesions

  Day 1

• Size

  Day 1

• Anatomical site

  Day 1

Study Arms (2)

Standard colonoscopy (S)

ACTIVE COMPARATOR

A standard colonoscopy will be performed.

Procedure: Standard colonoscopy

AEV assisted colonoscopy (E)

EXPERIMENTAL

Colonoscopy with ARC Endocuff Vision attached to the top of the scope will be performed.

Device: ARC Endocuff Vision

Interventions

Standard colonoscopy PROCEDURE

Current standard of care colonoscopy.

Standard colonoscopy (S)

ARC Endocuff Vision DEVICE

Subjects randomized to undergo a colonoscopy procedure with ARC Endocuff Vision will have this device placed on the top of the colonoscope used during their procedure.

AEV assisted colonoscopy (E)

Eligibility Criteria

• Age: 50 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject with a positive FIT result in the frame of national screening program

You may not qualify if:

• Subjects younger than 50 years old
• Active Inflammatory Bowel Disease
• Known condition of cholic stenosis
• Acute diverticulitis
• Patient not able to sign a informed consent form

Sponsors & Collaborators

• Cancer Prevention and Research Institute, Italy: lead
• Veneto Tumor Registry, Azienda Zero, Padua, Italy: collaborator

Study Sites (12)

Santa Maria del Prato, Local Health Unit 1 Dolomiti, Veneto Region

Feltre, Belluno, 32032, Italy

NOT YET RECRUITING

San Martino Hospital, Local Health Unit 1 Dolomiti, Veneto Region

Belluno, BL, 32100, Italy

NOT YET RECRUITING

Maggiore Hospital, Crema Territorial Health Care Company, Lombardia Region

Crema, Cremona, 26013, Italy

RECRUITING

Cazzavillan Hospital, Local Health Unit 8 Berica, Veneto Region

Arzignano, Vicenza, 36071, Italy

NOT YET RECRUITING

Screening Unit, Oncological Network, Prevention and Research Institute

Florence, 50139, Italy

RECRUITING

San Paolo Hospital Company - University Campus

Milan, 20142, Italy

NOT YET RECRUITING

Sant'Antonio Hospital, Local Health Unit 6 Euganea, Veneto Region

Padua, 35127, Italy

NOT YET RECRUITING

Veneto Tumor Registry, Local Health Unit 4, Veneto Region

Padua, 35131, Italy

ACTIVE NOT RECRUITING

Santa Maria della Misericordia Hospital, Local Health Unit 5 Polesana, Veneto Region

Rovigo, 45100, Italy

NOT YET RECRUITING

Ca' Foncello Hospital, Local Health Unit 2 Marca Trevigiana, Veneto Region

Treviso, 31100, Italy

NOT YET RECRUITING

Molinette Hospital, Città della Salute e della Scienza University Hospital Company

Turin, 10126, Italy

NOT YET RECRUITING

San Bonifacio Hospital, Local Health Unit 9 Scaligera, Veneto Region

Verona, 37047, Italy

NOT YET RECRUITING

Related Publications (17)

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• Rex DK, Cutler CS, Lemmel GT, Rahmani EY, Clark DW, Helper DJ, Lehman GA, Mark DG. Colonoscopic miss rates of adenomas determined by back-to-back colonoscopies. Gastroenterology. 1997 Jan;112(1):24-8. doi: 10.1016/s0016-5085(97)70214-2.

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  PMID: 33524994 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Gianni Amunni, MD

  Oncological Network, Prevention and Research Institute

  STUDY DIRECTOR

Central Study Contacts

Grazia Grazzini, MD

CONTACT

003905532697972; g.grazzini@ispro.toscana.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not be informed about diagnostic procedure in order to evaluate the acceptability of the exam with or without the studied device (in fact at the end of the examination care provider will ask participant about perceived pain during the procedure through the VAS score).
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized in two arms: a control-arm and an experimental-arm. Then arms data will be compared.

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: August 2, 2018
• Study Start: April 4, 2018
• Primary Completion: April 1, 2019
• Study Completion: August 1, 2019
• Last Updated: August 2, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (12)