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

Colorectal Adenoma Clinical Trial

— FUSETM-Colon  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02859870
• Other study ID #: FUSE-TM-Colon-IPC 2015-002
• Status: Completed
• Phase: N/A
• First received: August 2, 2016
• Last updated: August 16, 2017
• Start date: March 18, 2015
• Est. completion date: April 30, 2016

Study information

• Verified date: August 2017
• Source: Institut Paoli-Calmettes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: April 30, 2016
• Est. primary completion date: April 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Colorectal Adenoma

Intervention

Device:
• FUSE-TM colonoscope
Colonoscopy in conditions of normal security including patient clinical examination before leaving the hospital. Data collection by each operator.

Locations

Country	Name	City	State
France	Institut Paoli Cakmettes	Marseille	Bouches du Rhône

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy	Cecal intubation rate	1 day
Primary	Efficacy	Absence of necessity to change of endoscope in case of progression, visualization, biopsy or resection	1 day
Secondary	Toxicity	Serious adverse events (perforation, uncontrolled bleeding)	1 day