CClinicalTrials.gg
Status unknownNCT03350555Updated Nov 22, 2017

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

An interventional study of Additioned Endoscopy in ERCP, sponsored by Changhai Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-11-22.

Sponsored by Changhai Hospital · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Nov 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • ERCP
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • People who are indicated to ERCP treatment.

Exclusion criteria

Exclusion Criteria:

  • People who are not suitable for ERCP treatment.
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    ERCP with additioned endoscopy

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

    Device: Additioned Endoscopy

  • No intervention
    ERCP without additioned endoscopy

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

Interventions

  • DeviceAdditioned Endoscopy

    To evaluate the use of additioned endoscopy in ERCP treatment.

05

What researchers measure

Primary outcomes

  1. Duration of ERCP treatment

    To test if additioned endoscopy will have impact on duration of ERCP treatment

    Time frame: Duration of operation in each patient, ie. from beginning to the end of ERCP operation in each patient

Secondary outcomes

  1. complications of ERCP treatment

    To test if additioned endoscopy will have impact on incidence of ERCP complications, including perforation, bleeding, post-ERCP pancreatitis.

    Time frame: up to 1 month after ERCP completion

06

Study locations

1 of 1 sites recruiting
  • Changhai Hospital, Second Military Medical University
    Shanghai, Shanghai 200433, China
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03350555
Lead sponsor
Changhai Hospital
Responsible party
Xiangyu Kong (Doctor of gastroenterology department, Changhai Hospital) — Principal investigator
First posted
Nov 22, 2017
Start date
Nov 2017 (estimated)
Primary completion
Dec 2019 (estimated)
Completion
Dec 2019 (estimated)
Last update
Nov 22, 2017

Study contacts

Xiangyu Kong, MD
Contact
xiaoniu185@qq.com
13564644397
Zhaoshen Li, MD
study chair · Changhai Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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