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NCT06694038 · ClinicalTrials.gov registry record · Phase 1

Needle-Knife Fistulotomy Vs. Standard Cannulation Trial

A Phase 1 study of Biliary Obstruction Due to Common Bile Duct Stone and Malignant Bile Duct Obstruction, sponsored by Thomas Jefferson University.

Completed
Registry status
Phase 1
Development phase
186
Enrollment target
1
Study location

NCT06694038 is a Phase 1 study of Biliary Obstruction Due to Common Bile Duct Stone and Malignant Bile Duct Obstruction that has completed, run by Thomas Jefferson University. The registered enrollment target is 186 participants. The trial reports 1 study location across 1 state.

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The verdict

NCT06694038, a Phase 1 study of Biliary Obstruction Due to Common Bile Duct Stone and Malignant Bile Duct Obstruction, has completed, sponsored by Thomas Jefferson University.

COMPLETED
Registry status
Phase 1
Development phase
186 participants
Enrollment target
1
Study location

Study Summary

Needle-knife fistulotomy (NKF) is traditionally used to achieve biliary access when standard cannulation (SC) techniques are unsuccessful. Based on technical factors and the design of prior studies, the literature suggests NKF should be reserved for expert advanced endoscopists. The aim of this study was to evaluate the efficacy and safety of NKF compared to SC for primary biliary access performed by advanced endoscopists with a range of experience including advanced endoscopy trainees.

Interventions

  • PROCEDURE Needle Knife Fistulotomy
  • PROCEDURE standard biliary cannulation

Study Locations (1)

Pennsylvania

  • Thomas Jefferson University Hospial - Philadelphia

Trial Details

FieldValue
Enrollment Target 186 participants
Start Date 2019-01-31
Est. Completion 2021-07-01
Phase Phase 1

Sponsor

Thomas Jefferson University

292 total trials

What the Registry Record Tells You About NCT06694038

The ClinicalTrials.gov registry entry for NCT06694038 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 186 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Thomas Jefferson University, which has 292 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Biliary Obstruction Due to Common Bile Duct Stone appearing as the primary indexed condition, and to 2 interventions - of which Needle Knife Fistulotomy is the first listed.

NCT06694038 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT06694038 about?

NCT06694038 is a clinical study titled "Needle-Knife Fistulotomy Vs. Standard Cannulation Trial". Needle-knife fistulotomy (NKF) is traditionally used to achieve biliary access when standard cannulation (SC) techniques are unsuccessful. Based on technical factors and the design of prior studies, the literature suggests NKF should be reserved for expert advanced endoscopists. The aim of this stud...

What is the current status of trial NCT06694038?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 186 participants. The study started on 2019-01-31. Estimated completion is 2021-07-01.

What conditions does trial NCT06694038 study?

This clinical trial studies the following conditions: Biliary Obstruction Due to Common Bile Duct Stone, Malignant Bile Duct Obstruction.

What interventions are being tested in trial NCT06694038?

The interventions under investigation include: Needle Knife Fistulotomy (PROCEDURE), standard biliary cannulation (PROCEDURE).

Who is sponsoring clinical trial NCT06694038?

This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06694038 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.