Adenoma of the Accessory PapillaFUSE-TM-DuoNCT02859883
Evaluation of Oesogastroduodenoscopy With Vision to 245 ° (Full Spectrum Endoscopy) to View the Main Disc and Accessory
An observational study of Adenoma of the Accessory Papilla and Ampulloma of the Accessory Papilla, run by Institut Paoli-Calmettes at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenoma of the Accessory Papilla, Ampulloma of the Accessory Papilla
- What is being tested?
- gastroscope FUSE™
- Type of treatment
- Medical device
- How many people
- 73 participants
- Where
- 1 siteFrance
- Study dates
- 18 Mar 2015to 31 May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient eligible to any upper gastrointestinal endoscopy diagnostic
Who may be able to join
- Patient eligible to any upper gastrointestinal endoscopy diagnostic
Who cannot join
- History of duodenal or gastric surgery
Trial locations and contacts
1 site in 1 country.
About this study
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 .
- Being tested
- gastroscope FUSE™
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Visualization of minor and major papilla Absence of necessity to change endoscope for viewing and / or for biopsies
Measured: 1 day
Secondary outcomes (1)
Number of patient with treatment-related serious adverse events
Evaluated serious advers events are mainly perforation, severe bleeding, acute pancreatitis
Measured: 5 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study start18 Mar 2015
- Primary completion31 May 2016
- Study completion31 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Adenoma of the Accessory PapillaStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Philippe RATONE, MD, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02859883
- Sponsor's protocol ID
- FUSE-TM-Duodénum-IPC 2015-001
- Acronym
- FUSE-TM-Duo
- Status last verified
- Apr 2016
- First submitted
- 2 Aug 2016
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23939509Gralnek 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.
PubMed 24560453Moussata 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.
PubMed 24814771
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Oesogastroduodenoscopy With Vision to 245 ° (Full Spectrum Endoscopy) to View the Main Disc and Accessory
- ClinicalTrials.gov ID
- NCT02859883
- Acronym / sponsor ID
- FUSE-TM-Duo / FUSE-TM-Duodénum-IPC 2015-001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 18 Mar 2015 (actual)
- Primary completion
- 31 May 2016 (actual)
- Study completion
- 31 May 2016 (actual)
- First posted
- 9 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient eligible to any upper gastrointestinal endoscopy diagnostic
Key inclusion criteria (1 listed)
- Patient eligible to any upper gastrointestinal endoscopy diagnostic
Key exclusion criteria (1 listed)
- History of duodenal or gastric surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | – |
Primary outcome
Efficacy
Time frame: 1 day
Visualization of minor and major papilla Absence of necessity to change endoscope for viewing and / or for biopsies
1 secondary outcome
Number of patient with treatment-related serious adverse events
Time frame: 5 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
- Background: PubMed 23939509Gralnek 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.
- Background: PubMed 24560453Gralnek 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.
- Background: PubMed 24814771Moussata 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Philippe RATONE, MD principal investigator
Institut Paoli-Calmettes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenoma of the Accessory Papilla and Ampulloma of the Accessory Papilla, run by Institut Paoli-Calmettes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02859883, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2017.