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

NCT ID: NCT04519138

Last Updated: 2021-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-30

Study Completion Date

2021-11-30

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.

Conditions

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Tumor Sampling

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

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.

Study Groups

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Endodrill Model X

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

Group Type EXPERIMENTAL

Endodrill Model X

Intervention Type DEVICE

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

Endoscopic ultrasound guided fine-needle aspiration/biopsy

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

Group Type ACTIVE_COMPARATOR

Fine-needle aspiration/biopsy

Intervention Type DEVICE

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

Interventions

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Endodrill Model X

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

Intervention Type DEVICE

Fine-needle aspiration/biopsy

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

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bibb Instruments AB

UNKNOWN

Sponsor Role collaborator

Key2Compliance

INDUSTRY

Sponsor Role collaborator

Region Skane

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fredrik Swahn, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Skane University hospital, Lund, Sweden

Locations

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Linköping University Hospital

Linköping, , Sweden

Site Status

Skane University Hospital

Lund, , Sweden

Site Status

Örebro University Hospital

Örebro, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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BIBB EDMX01

Identifier Type: -

Identifier Source: org_study_id