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

• ClinicalTrials.gov Identifier: NCT04519138
• Recruitment Status: Completed
• First Posted: August 19, 2020
• Last Update Posted: December 2, 2021
• Sponsor: Region Skane
• Collaborators: Bibb Instruments AB; Key2Compliance
• Information provided by (Responsible Party): Region Skane

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Tumor Sampling	Device: Endodrill Model X; Device: Fine-needle aspiration/biopsy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 7 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: 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.
• Masking: None (Open Label)
• Masking Description: 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.
• Primary Purpose: Diagnostic
• Official Title: Safety and Efficacy of the Endodrill Model X Biopsy Instrument When Sampling Tumours in the Upper Gastrointestinal Tract
• Actual Study Start Date: September 30, 2020
• Actual Primary Completion Date: November 30, 2021
• Actual Study Completion Date: November 30, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Sweden

Linköping University Hospital

Linköping, Sweden, 581 85

Skane University Hospital

Lund, Sweden, 251 87

Örebro University Hospital

Örebro, Sweden, 701 85

Sponsors and Collaborators

Region Skane

Bibb Instruments AB

Key2Compliance

Investigators

• Principal Investigator: Fredrik Swahn, MD, PhD; Skane University hospital, Lund, Sweden

More Information

• Responsible Party: Region Skane
• ClinicalTrials.gov Identifier: NCT04519138
• Other Study ID Numbers: BIBB EDMX01
• First Posted: August 19, 2020
• Last Update Posted: December 2, 2021
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Region Skane:

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