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

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ClinicalTrials.gov Identifier: NCT02859883
Recruitment Status : Completed
First Posted : August 9, 2016
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
Institut Paoli-Calmettes

Study Description
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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 .

Condition or disease Intervention/treatment
Adenoma of the Accessory Papilla Ampulloma of the Accessory Papilla Device: gastroscope FUSE™

Study Design
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Study Type : Observational
Actual Enrollment : 73 participants
Observational Model: Cohort
Time Perspective: Prospective
Actual Study Start Date : March 18, 2015
Actual Primary Completion Date : May 31, 2016
Actual Study Completion Date : May 31, 2016
Groups and Cohorts
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Intervention Details:
  • 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.

Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient eligible to any upper gastrointestinal endoscopy diagnostic
Criteria

Inclusion Criteria:

  • Patient eligible to any upper gastrointestinal endoscopy diagnostic

Exclusion Criteria:

  • History of duodenal or gastric surgery
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02859883


Locations
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France
Institut Paoli Calmettes
Marseille, Bouches du Rhone, France, 13009
Sponsors and Collaborators
Institut Paoli-Calmettes
Investigators
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Principal Investigator: Jean-Philippe RATONE, MD Institut Paoli-Calmettes
More Information
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Publications:

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Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT02859883    
Other Study ID Numbers: FUSE-TM-Duodénum-IPC 2015-001
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: April 2016
Additional relevant MeSH terms:
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Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms