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Completed

NCT Number: NCT04519138

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

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.

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Key information

Conditions

Tumor Sampling Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Linköping University Hospital, Linköping, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endodrill Model X

Device

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

Fine-needle aspiration/biopsy

Device

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

Primary outcomes

  1. Proportion of patients with pre-specified adverse events

    Time frame: 10 days

    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

Secondary outcomes

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

    Time frame: Day 0 (day of biopsy)

    Visual confirmation of the biopsies size > 5 mm or not, will be recorded at the examination. Analysis will be performed at each hospitals department of pathology as all biopsy samples are routinely handled. A copy of the pathology report will recorded in the Contact Report Form (CRF) at day 14 when the study report for each patient is concluded

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Collaborators

  • Bibb Instruments AB
  • Key2Compliance

Registry information

Official study title

Safety and Efficacy of the Endodrill Model X Biopsy Instrument When Sampling Tumours in the Upper Gastrointestinal Tract

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 19, 2020
Registry last updated
Dec 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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