Endoscopic Ultrasound (EUS) Fine Needle Biopsy (FNB) Submucosal Nodule

Duke University

Status: Withdrawn

Conditions: GI Lesions

Treatments: Device: Pro Core Needle; Device: medtronic Sharkcore Needle

Study type: Interventional

Funder types: Other

Identifiers

NCT03011229

Pro00077315

Details and patient eligibility

About

The purpose of this study is to compare the diagnostic accuracy of a novel endoscopic ultrasound (EUS) biopsy needle to the current standard EUS needle.

The investigators hypothesize that with the SharkcoreTM needle a diagnostic yield of 90% is possible for subepithelial lesions (SEL) within the Gastrointestinal (GI) tract versus 60% yield with the current needle.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients age 18 or older referred for EUS found to have a hypoechoic lesion > 8 mm within the GI lumen arising from the muscularis propria, as determined by EUS.
• Women that have a negative pregnant test

Exclusion criteria

• Patients under the age of 18.
• Uncorrectable coagulopathy (INR>1.5)
• Uncorrectable thrombocytopenia (platelet count <50,000)
• Patient who is unable to comply with study requirements
• Pregnant women
• Female patients who are not tested per our current unit protocol
• Refusal to consent or unable to provide informed consent

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

0 participants in 2 patient groups

Pro Core

Active Comparator group

Description:

Subject is randomized to ProCore standard needle.

Treatment:

Device: Pro Core Needle

Medtronic Shark Core

Experimental group

Description:

Subject is randomized to Medtronic Sharkcore needle

Treatment:

Device: medtronic Sharkcore Needle