MedDataX Logo

Clinical Trials to Validate the Use of Additioned Endoscopy in Endoscopic Retrograde Cholangiopancreatography

NCT ID: NCT03350555

Last Updated: 2017-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-30

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Validation of clinical use of additioned endoscopy in Endoscopic Retrograde Cholangiopancreatography(ERCP) treatment.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Investigators recently developed a device named additioned Endoscopy. The purpose of current clinical trial is to evaluate the use of additioned endoscopy in ERCP treatment, specifically in shortening the duration of ERCP operation and lowering incidence of complications.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

ERCP

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

One arm includes participants who will receive additioned endoscopy assisted ERCP, and the other arm includes participants who will not receive additioned endoscopy assisted ERCP.
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ERCP with additioned endoscopy

This arm will include participants undergoing ERCP with assistance of additioned endoscopy.

Group Type EXPERIMENTAL

Additioned Endoscopy

Intervention Type DEVICE

To evaluate the use of additioned endoscopy in ERCP treatment.

ERCP without additioned endoscopy

This arm will include participants undergoing ERCP without assistance of additioned endoscopy as negative controls.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Additioned Endoscopy

To evaluate the use of additioned endoscopy in ERCP treatment.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* People who are indicated to ERCP treatment.

Exclusion Criteria

* People who are not suitable for ERCP treatment.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Xiangyu Kong

Doctor of gastroenterology department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Zhaoshen Li, MD

Role: STUDY_CHAIR

Changhai Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Changhai Hospital, Second Military Medical University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Xiangyu Kong, MD

Role: CONTACT

Phone: 13564644397

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

zhaoshen Li, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Additioned Endocopy in ERCP

Identifier Type: -

Identifier Source: org_study_id