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NCT02859883 Clinical Trial

Evaluation of Oesogastroduodenoscopy With Vision to 245 ° (Full Spectrum Endoscopy) to View the Main Disc and Accessory

Adenoma of the Accessory Papilla Clinical Trial

— FUSE-TM-Duo  

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02859883
Other study ID # FUSE-TM-Duodénum-IPC 2015-001
Secondary ID
Status Completed
Phase N/A
First received August 2, 2016
Last updated October 25, 2017
Start date March 18, 2015
Est. completion date May 31, 2016

Study information
Verified date April 2016
Source Institut Paoli-Calmettes
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The monitoring and prognosis of patients with familial polyposis adenomatous rests on analysis of the transitional mucosa at the anal margin and especially on the tracking, characterization and resection of lesions of dysplasia type of high grade at the duodenal level, after total proctocolectomy. Currently, endoscopes with axial or lateral vision are used. The FUSE technology allows the simplification or even the improvement of patient surveillance with a 245° vision (versus150° in case of classical gastroscope). The use of a second screen to enlarge the field of view may allow both analysis of duodenum and the main and accessory papilla with one single endoscope and to decrease the number of omitted lesions .

Recruitment information / eligibility
Status Completed
Enrollment 73
Est. completion date May 31, 2016
Est. primary completion date May 31, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patient eligible to any upper gastrointestinal endoscopy diagnostic

Exclusion Criteria:

- History of duodenal or gastric surgery

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• gastroscope FUSE™
All patients undergoing a diagnostic gastroscopy are eligible. Using the FUSE endoscope with side screen, the duodenal and accessory papilla are monitored. Data are collected by each operator. Clinical examination of patients is performed before they leave the centre.

Locations
Country Name City State
France Institut Paoli Calmettes Marseille Bouches du Rhone

Sponsors (1)
Lead Sponsor Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

References & Publications (3)

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

Moussata D, Napoleon B, Lepilliez V, Klich A, Ecochard R, Lapalus MG, Nancey S, Cenni JC, Ponchon T, Chayvialle JA, Saurin JC. Endoscopic treatment of severe duodenal polyposis as an alternative to surgery for patients with familial adenomatous polyposis. Gastrointest Endosc. 2014 Nov;80(5):817-25. doi: 10.1016/j.gie.2014.03.012. Epub 2014 May 6. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy Visualization of minor and major papilla Absence of necessity to change endoscope for viewing and / or for biopsies 1 day
Secondary Number of patient with treatment-related serious adverse events Evaluated serious advers events are mainly perforation, severe bleeding, acute pancreatitis 5 day