|- candidate number||28385|
|- NTR Number||NTR6928|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||28-dec-2017|
|- Secondary IDs||2017-3505 CMO Radboudumc|
|- Public Title||Detection of Barrett¡¯s esophagus through exhaled breath using an electronic nose device (AeoNoseTM)|
|- Scientific Title||Detection of Barrett¡¯s Esophagus through Exhaled Breath using an Electronic Nose Device (AeoNoseTM)|
|- Healt Condition(s) or Problem(s) studied||Barrett's esophagus, Gastroesophageal reflux Disease (GERD), Esophageal Adenocarcinoma (EAC)|
|- Inclusion criteria||Subjects, who are:|
- Aged 18 years or older.
- Able to give signed informed consent.
1. Patients with known Barrett's Esophagus (BE), who are.
- Diagnosed with a BE segment >1cm in maximal extent endoscopically (CxM1).
- Histology showing evidence of intestinal metaplasia without presence of dysplasia.
- Undergoing clinically indicated (surveillance) endoscopy.
2. Individuals with reflux symptoms without BE, who are.
- Undergoing clinically indicated diagnostic endoscopy due to upper gastrointestinal symptoms (non-acute symptoms of heartburn, pain in the epigastric region or bloating, with the cause likely to be located in the upper gastrointestinal tract).
- GerdQ self-assessment questionnaire score ¡Ý 8.
3. Healthy individuals without BE and without reflux symptoms, who are
- Undergoing clinically indicated diagnostic endoscopy.
- GerdQ self-assessment questionnaire score < 6.
|- Exclusion criteria||•Patients with a history of any type of malignancy (not including basal-cell skin cancer (BCC) and squamous-cell skin cancer (SCC))|
• Patients with prior history of ablation (photodynamic therapy, radiofrequency ablation, cryotherapy, argon plasma coagulation) or endoscopic mucosal resection.
• Patients with history of esophageal or gastric resection or surgery which has changed the esophageal anatomy.
•Patients who are unable to perform breathing maneuver needed for Aeonose-analysis of exhaled air
|- mec approval received||no|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||Single arm|
|- planned startdate ||1-jan-2018|
|- planned closingdate||1-jul-2018|
|- Target number of participants||225|
|- Interventions||Device: Aeonose |
An electronic nose device is an artificial olfactory system that analyses volatile organic compounds (VOCs) in exhaled breath. The AeonoseTM is a handheld device of 650 gram. A nose clip will be used to prevent the entry of non-filtered air and patients will be instructed to enclose the mouthpiece with their mouth at all times. A measurement cycle lasts for about 15 minutes, of which 5 minutes of in-and exhalation by the patient takes place.
|- Primary outcome||The ability to distinguish between patients with BE, healthy individuals, and patients with reflux symptoms by eNose in terms of sensitivity, specificity and accuracy.|
|- Secondary outcome||Cross-validated accuracy with which the eNose can distinguish between patients with BE, healthy individuals and patients with reflux symptoms, defined as the percentage of correctly classified patients using the leave-some out method.|
- Acceptance rate of using the eNose
|- Timepoints||time frame: 1 year|
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD Yonne Peters|
|- CONTACT for SCIENTIFIC QUERIES||MD Peter D. Siersema|
|- Sponsor/Initiator ||Radboud University Medical Center Nijmegen|
(Source(s) of Monetary or Material Support)
|Radboud University Medical Center Nijmegen|
|- Brief summary||The current study will be a multi-center cross-sectional, exploratory proof of principle study to explore whether an electronic nose device (Aeonose (the eNose Company, Zutphen, the Netherlands)) is able to distinguish patients with BE from those without BE by VOC analysis of patient breath samples.|
|- Main changes (audit trail)|
|- RECORD||28-dec-2017 - 9-mrt-2018|