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

NCT04519138 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2021-12-02

No results posted yet for this study

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.

Conditions

  • Tumor Sampling

Interventions

DEVICE

Endodrill Model X

The investigational device Endodrill Model X is used for biopsy sampling in the upper gastrointestinal tract

DEVICE

Fine-needle aspiration/biopsy

The standard method is used for biopsy sampling in the upper gastrointestinal tract

Sponsors & Collaborators

  • Bibb Instruments AB

    collaborator UNKNOWN

  • Key2Compliance

    collaborator INDUSTRY

  • Region Skane

    lead OTHER

Principal Investigators

  • Fredrik Swahn, MD, PhD · Skane University hospital, Lund, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-30
Primary Completion
2021-11-30
Completion
2021-11-30

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04519138 on ClinicalTrials.gov