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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02859883
Acronym
FUSE-TM-Duo
Enrollment
73
Registered
2016-08-09
Start date
2015-03-18
Completion date
2016-05-31
Last updated
2017-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenoma of the Accessory Papilla, Ampulloma of the Accessory Papilla

Brief 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 .

Interventions

DEVICEgastroscope 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.

Sponsors

Institut Paoli-Calmettes
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patient eligible to any upper gastrointestinal endoscopy diagnostic

Exclusion criteria

* History of duodenal or gastric surgery

Design outcomes

Primary

MeasureTime frameDescription
Efficacy1 dayVisualization of minor and major papilla Absence of necessity to change endoscope for viewing and / or for biopsies

Secondary

MeasureTime frameDescription
Number of patient with treatment-related serious adverse events5 dayEvaluated serious advers events are mainly perforation, severe bleeding, acute pancreatitis

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026