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

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

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.

Study Overview

• Status: Completed
• Conditions: Tumor Sampling
• Intervention / Treatment: Device: Endodrill Model X; Device: Fine-needle aspiration/biopsy

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Linköping, Sweden, 581 85
    • Linköping University Hospital
  • Lund, Sweden, 251 87
    • Skane University Hospital
  • Örebro, Sweden, 701 85
    • Orebro University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endodrill Model X; Three consecutive samples will be taken using the Endodrill Model X instrument.	Device: Endodrill Model X; The investigational device Endodrill Model X is used for biopsy sampling in the upper gastrointestinal tract
Active Comparator: Endoscopic ultrasound guided fine-needle aspiration/biopsy; Three consecutive samples will be taken using the the standard method fine-needle aspiration/biopsy.	Device: Fine-needle aspiration/biopsy; The standard method is used for biopsy sampling in the upper gastrointestinal tract

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of visible biopsy material over or under 5 mm at endoscopy examination	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	Day 0 (day of biopsy)

Collaborators and Investigators

• Sponsor: Region Skane
• Collaborators: Bibb Instruments AB; Key2Compliance
• Investigators: Principal Investigator: Fredrik Swahn, MD, PhD, Skane University Hospital, Lund, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2020
• Primary Completion (Actual): November 30, 2021
• Study Completion (Actual): November 30, 2021

Study Registration Dates

• First Submitted: August 17, 2020
• First Submitted That Met QC Criteria: August 17, 2020
• First Posted (Actual): August 19, 2020

Study Record Updates

• Last Update Posted (Actual): December 2, 2021
• Last Update Submitted That Met QC Criteria: December 1, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Diagnosis; Methods; Gastrointestinal; Medical device; Image-Guided Biopsy; Endoscope; Fine-Needle
• Other Study ID Numbers: BIBB EDMX01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No