Clinical trial NCT04519138: Investigation to Evaluate Safety and Efficacy of the Endodrill Model X Biopsy Instrument
Official title: Safety and Efficacy of the Endodrill Model X Biopsy Instrument When Sampling Tumours in the Upper Gastrointestinal Tract
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tumor Sampling
Keywords: Endoscope
Gastrointestinal
Image-Guided Biopsy
Fine-Needle
Medical device
Methods
Diagnosis
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Bibb Instruments AB
name: Key2Compliance
First posted: 2020-08-19
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients with pre-specified adverse events
timeFrame: 10 days
Secondary outcomes:
measure: Amount of visible biopsy material over or under 5 mm at endoscopy examination
timeFrame: Day 0 (day of biopsy)
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Linköping University Hospital
city: Lund
country: Sweden
facility: Skane University Hospital
city: Örebro
country: Sweden
facility: Örebro University Hospital
Study officials:
affiliation: Skane University hospital, Lund, Sweden
name: Fredrik Swahn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: