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

Region Skane

Status: Completed

Conditions: Tumor Sampling

Treatments: Device: Fine-needle aspiration/biopsy; Device: Endodrill Model X

Study type: Interventional

Funder types: Other

Identifiers

NCT04519138

BIBB EDMX01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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7 participants in 2 patient groups

Endodrill Model X

Experimental group

Description:

Three consecutive samples will be taken using the Endodrill Model X instrument.

Treatment:

Device: Endodrill Model X

Endoscopic ultrasound guided fine-needle aspiration/biopsy

Active Comparator group

Description:

Three consecutive samples will be taken using the the standard method fine-needle aspiration/biopsy.

Treatment:

Device: Fine-needle aspiration/biopsy