NCT03701958

Brief Summary

To confirm procedural performance of the Exalt single-use duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) procedures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 10, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

April 15, 2019

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2019

Completed
Last Updated

February 8, 2022

Status Verified

August 1, 2019

Enrollment Period

21 days

First QC Date

July 31, 2018

Last Update Submit

February 4, 2022

Conditions

Endoscopic Retrograde Cholangiopancreatography

Outcome Measures

Primary Outcomes (1)

  • Successful ERCP procedure

    The ability to complete the ERCP procedure for the intended indication(s); outcome reported as "success" or "failure". Examples include but are not limited to: biliary stent placement, pancreatic stent placement, sphincterotomy, and clearance of bile duct stones.

    Procedure success is assessed at the end of the procedure (within 24 hours on study day 1).

Secondary Outcomes (3)

  • Endoscopist qualitative rating

    Endoscopists will rate their experience with the Exalt single-use duodenoscope immediately following the completion of the study procedure (within 24 hours on study day 1).

  • Incidence of crossover from Exalt single-use duodenoscope to reusable duodenoscope

    Incidence of crossover is monitored throughout the procedure (within 24 hours on study day 1).

  • Evaluation of adverse events (SAEs) related to the device and/or the procedure

    SAEs are assessed through 7 days after the procedure.

Study Arms (1)

Exalt DScope 01

OTHER

Subjects will have a clinically indicated per standard of care ERCP procedure performed using the Exalt single use duodenoscope study device. Subjects are considered enrolled after completing the study specific informed consent form.

Device: Exalt Model D Single-Use Duodenoscope

Interventions

Exalt Model D Single-Use DuodenoscopeDEVICE

Subjects will have a clinically indicated per standard of care ERCP procedure performed with the Exalt single use duodenoscope study device.

Exalt DScope 01

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
  • Scheduled for a clinically indicated ERCP

You may not qualify if:

  • Altered pancreaticobiliary anatomy
  • Potentially vulnerable subjects, including, but not limited to pregnant women
  • Subjects for whom endoscopic techniques are contraindicated
  • Patients who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor
  • Investigator discretion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Ronald Reagan University of California Los Angeles Medical Center

Los Angeles, California, 90095, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Related Publications (1)

  • Muthusamy VR, Bruno MJ, Kozarek RA, Petersen BT, Pleskow DK, Sejpal DV, Slivka A, Peetermans JA, Rousseau MJ, Tirrell GP, Ross AS. Clinical Evaluation of a Single-Use Duodenoscope for Endoscopic Retrograde Cholangiopancreatography. Clin Gastroenterol Hepatol. 2020 Aug;18(9):2108-2117.e3. doi: 10.1016/j.cgh.2019.10.052. Epub 2019 Nov 6.

    PMID: 31706060DERIVED

Study Officials

  • V. Raman Muthusamy, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

  • Andrew Ross, MD

    Virginia Mason Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2018

First Posted

October 10, 2018

Study Start

April 15, 2019

Primary Completion

May 6, 2019

Study Completion

June 7, 2019

Last Updated

February 8, 2022

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

US(6)