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

NCT04519138 | Completed

• 1 other identifier: BIBB EDMX01
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 3

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.

Conditions

Tumor Sampling

Keywords

Endoscope; Gastrointestinal; Image-Guided Biopsy; Fine-Needle; Medical device; Methods; Diagnosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Amount of visible biopsy material over or under 5 mm at endoscopy examination

  Day 0 (day of biopsy)

Study Arms (2)

Endodrill Model X

EXPERIMENTAL

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

Device: Endodrill Model X

Endoscopic ultrasound guided fine-needle aspiration/biopsy

ACTIVE COMPARATOR

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

Device: Fine-needle aspiration/biopsy

Interventions

Endodrill Model X DEVICE

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

Endodrill Model X

Fine-needle aspiration/biopsy DEVICE

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

Endoscopic ultrasound guided fine-needle aspiration/biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Submucosal tumor of the upper gastrointestinal tract with tumor size ≥ 10 mm, well localized by the endoscopic examination

You may not qualify if:

• Suspicion of vascular tumor (e.g. pulsating tumor)
• Ongoing treatment with anticoagulants (e.g. Warfarin)
• Ongoing treatment with immunosuppressive drugs
• Pregnancy

Sponsors & Collaborators

• Region Skane: lead
• Bibb Instruments AB: collaborator
• Key2Compliance: collaborator

Study Sites (3)

Linköping University Hospital

Linköping, 581 85, Sweden

Location

Skane University Hospital

Lund, 251 87, Sweden

Location

Örebro University Hospital

Örebro, 701 85, Sweden

Location

MeSH Terms

Conditions

Disease

Interventions

Biopsy, Fine-Needle

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures; Investigative Techniques

Study Officials

• Fredrik Swahn, MD, PhD

  Skane University hospital, Lund, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 19, 2020
• Study Start: September 30, 2020
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: December 2, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)