Evaluation of the Colonoscope With Vision to 330 ° (Full Spectrum Endoscopy) in the Detection of Colorectal Adenomas

NCT ID: NCT02859870

Last Updated: 2017-08-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 141 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-18
• Study Completion Date: 2016-04-30

Brief Summary

The coloscopy is considered as the gold standard for screening and resection of colorectal adenomas. However the literature reports that the rate of omitted adenoma is still high (24 to 41%). The development of the FUSE system (Endochoice, USA) allows a larger field of view with a projection onto 3 screens (330° vision). A pilot study and a randomized multicentre has demonstrated the feasibility with a significant improvement of the rate of detected adenomas. This first study in France concerning this technology has the objectives to demonstrate the feasibility in France, the safety and to compare the rate of detected adenomas with data of the literature.

Conditions

Colorectal Adenoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

FUSE-TM colonoscope

Colonoscopy in conditions of normal security including patient clinical examination before leaving the hospital. Data collection by each operator.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age >18 years
• Diagnostic colonoscopy

Exclusion Criteria

• Colorectal cancer
• Colic surgery
• Preparation of average or poor quality
• Rectal polyp of hyperplastic type <2 mm

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Paoli-Calmettes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Philippe RATONE, MD

Role: STUDY_DIRECTOR

Institut Paoli-Calmettes

Locations

Institut Paoli Cakmettes

Marseille, Bouches du Rhône, France

Countries

France

References

Gralnek IM, Segol O, Suissa A, Siersema PD, Carr-Locke DL, Halpern Z, Santo E, Domanov S. A prospective cohort study evaluating a novel colonoscopy platform featuring full-spectrum endoscopy. Endoscopy. 2013 Sep;45(9):697-702. doi: 10.1055/s-0033-1344395. Epub 2013 Aug 12.

Reference Type: BACKGROUND

PMID: 23939509 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24560453 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8978338 (View on PubMed)

Rex DK, Rahmani EY, Haseman JH, Lemmel GT, Kaster S, Buckley JS. Relative sensitivity of colonoscopy and barium enema for detection of colorectal cancer in clinical practice. Gastroenterology. 1997 Jan;112(1):17-23. doi: 10.1016/s0016-5085(97)70213-0.

Reference Type: BACKGROUND

PMID: 8978337 (View on PubMed)

Siersema PD, Rastogi A, Leufkens AM, Akerman PA, Azzouzi K, Rothstein RI, Vleggaar FP, Repici A, Rando G, Okolo PI, Dewit O, Ignjatovic A, Odstrcil E, East J, Deprez PH, Saunders BP, Kalloo AN, Creel B, Singh V, Lennon AM, DeMarco DC. Retrograde-viewing device improves adenoma detection rate in colonoscopies for surveillance and diagnostic workup. World J Gastroenterol. 2012 Jul 14;18(26):3400-8. doi: 10.3748/wjg.v18.i26.3400.

Reference Type: BACKGROUND

PMID: 22807609 (View on PubMed)

Other Identifiers

FUSE-TM-Colon-IPC 2015-002

Identifier Type: -

Identifier Source: org_study_id