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OpenTrials
Completed

NCT Number: NCT02859883

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

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 .

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut Paoli Calmettes

Marseille, Bouches du Rhone, 13009, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient eligible to any upper gastrointestinal endoscopy diagnostic

Exclusion criteria

  • History of duodenal or gastric surgery

Treatment and study plan

gastroscope FUSE™

Device

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.

Primary outcomes

  1. Efficacy

    Time frame: 1 day

    Visualization of minor and major papilla Absence of necessity to change endoscope for viewing and / or for biopsies

Secondary outcomes

  1. Number of patient with treatment-related serious adverse events

    Time frame: 5 day

    Evaluated serious advers events are mainly perforation, severe bleeding, acute pancreatitis

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Registry information

Acronym: FUSE-TM-Duo

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 9, 2016
Registry last updated
Oct 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.