Tumor Sampling
Conditions
Keywords
Endoscope, Gastrointestinal, Image-Guided Biopsy, Fine-Needle, Medical device, Methods, Diagnosis
Brief summary
This is an investigator led prospective open label investigation, performed at three clinics in Sweden, comparing the flexible endoscopic biopsy instrument Endodrill Model X with the standard sampling method endoscopic ultrasound fine needle aspiration/biopsy. Assessment of safety is the primary objective and performance is the secondary objective.
Detailed description
The investigation will include 20 patients with lesions and suspected tumors in the stomach, esophagus or duodenum (upper small intestine). The investigation will consist of one visit with an endoscopic examination with sampling of an observed lesion or suspected tumor. Six biopsies will be collected from each patient, three consecutive samples using the Endodrill Model X instrument and three consecutive samples using the standard fine needle. The order of instruments to be used will be randomly assigned. The patient will be under observation for 2 hours after the procedure. Telephone follow-up will be performed 1 and 7 days after the examination. Visual confirmation of the biopsies size will be recorded at the examination. If the samples verify a tumor or not will be evaluated at Day 14 when the pathology report is concluded.
Interventions
DEVICEEndodrill Model X
The investigational device Endodrill Model X is used for biopsy sampling in the upper gastrointestinal tract
DEVICEFine-needle aspiration/biopsy
The standard method is used for biopsy sampling in the upper gastrointestinal tract
Sponsors
Bibb Instruments AB
Key2Compliance
Region Skane
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
The order of the instruments to be used is blinded to the endoscopist until after the tumor has been visualized to avoid and minimize the influence of the choice of instrument of where the sample is taken. Closed envelopes prepared according to a randomization list stratified by site are available at each site. The envelope is opened by an assistant and not shown to the examiner until the tumor has been visualized.
Intervention model description
Both the Endodrill Model X device and the standard instrument are used on the same lesion and patient to evaluate both instruments and their functions under as similar circumstances as possible.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults at least 18 years of age at the day of inclusion * Signed informed consent * Submucosal tumor of the upper gastrointestinal tract with tumor size ≥ 10 mm, well localized by the endoscopic examination
Exclusion criteria
* Suspicion of vascular tumor (e.g. pulsating tumor) * Ongoing treatment with anticoagulants (e.g. Warfarin) * Ongoing treatment with immunosuppressive drugs * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with pre-specified adverse events | 10 days | Proportion of patients with one or more of the following: 1) non-intentional perforation of the sampled organ, 2) bleeding requiring open surgical intervention or treatment at an intensive care unit, 3) non-planned hospitalization for observation AND where the patient is not fully recovered within 10 days after the endoscopic examination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Amount of visible biopsy material over or under 5 mm at endoscopy examination | Day 0 (day of biopsy) | Visual confirmation of the biopsies size \> 5 mm or not, will be recorded at the examination. Analysis will be performed at each hospitals department of pathology as all biopsy samples are routinely handled. A copy of the pathology report will recorded in the Contact Report Form (CRF) at day 14 when the study report for each patient is concluded |
Countries
Sweden
Outcome results
None listed