The enose is able to detect BE through exhaled breath.
ID
Bron
Verkorte titel
Aandoening
Gastroesophageal reflux disease (GERD)
Barrett's Esophagus (BE)
Esophageal Adenocarcinoma (EAC)
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The ability to distinguish between patients with BE, healthy individuals, and patients with reflux symptoms by eNose in terms of sensitivity, specificity and accuracy.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
The enose is able to detect BE through exhaled breath.
Onderzoeksopzet
time frame: 1 year
Onderzoeksproduct en/of interventie
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.
Publiek
Yonne Peters
P.O. box 9101
Nijmegen 6500 HB
The Netherlands
+31615956464
y.peters@radboudumc.nl
Wetenschappelijk
Yonne Peters
P.O. box 9101
Nijmegen 6500 HB
The Netherlands
+31615956464
y.peters@radboudumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
•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
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6750 |
| NTR-old | NTR6928 |
| Ander register | CMO Radboudumc : 2017-3505 |