Investigation to Evaluate Safety and Efficacy of the Endodrill Model X Biopsy Instrument

Study Overview
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Brief Summary
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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
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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.

Official Title
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Safety and Efficacy of the Endodrill Model X Biopsy Instrument When Sampling Tumours in the Upper Gastrointestinal Tract

Conditions
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Tumor Sampling

Intervention / Treatment
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* Device: Endodrill Model X
* Device: Fine-needle aspiration/biopsy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endodrill Model X<br>Three consecutive samples will be taken using the Endodrill Model X instrument. | Device: Endodrill Model X<br>* The investigational device Endodrill Model X is used for biopsy sampling in the upper gastrointestinal tract<br>|
| Active Comparator: Endoscopic ultrasound guided fine-needle aspiration/biopsy<br>Three consecutive samples will be taken using the the standard method fine-needle aspiration/biopsy. | Device: Fine-needle aspiration/biopsy<br>* The standard method is used for biopsy sampling in the upper gastrointestinal tract<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with pre-specified adverse events | 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 | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of visible biopsy material over or under 5 mm at endoscopy examination | 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 | Day 0 (day of biopsy) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscope, Gastrointestinal, Image-Guided Biopsy, Fine-Needle, Medical device, Methods, Diagnosis