Clinical trial NCT04447976: Prospective Evaluation of Performance of Disposable Elevator Cap Duodenoscope During ERCP in Clinical Practice
Official title: A Multi-center Prospective Study to Evaluate Performance of Disposable TIP Duodenoscope Designed to Prevent Future Outbreak Related to Contaminated Duodenoscope.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ERCP
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Wake Forest University Health Sciences
name: Instituto Ecuatoriano de Enfermedades Digestivas
First posted: 2020-06-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be outpatients and inpatients undergoing ERCP at the Memorial Hermann Hospital Texas Medical Center. All patients will be seen by any one of the investigators either in the outpatient clinic or during inpatient consultation on hospitalized patients.

The physicians and Nurse technicians will be evaluating the performance of the TIP duodenoscope on these patients undergoing ERCP.

Brief summary: Purpose: To evaluate overall performance of disposable TIP duodenoscopes and get insight from end-users regarding its performance during various steps of ERCP procedure as well as ease and feasibility of pre-procedure duodenoscope set up and post procedure manual cleaning as well as reprocessing.

Research design: This is a prospective observational multi-center study. Procedure used: During ERCP

Risks and potential benefits: There are no risks associated with this study as it is a retrospective chart review. Potential benefits include the knowledge gained from this study which may be of help to patients in the future.

Importance of knowledge that may reasonably be expected to result: The quality of health care which will be crucial to identify patterns of competence and identify areas of continued improvement. More specifically in the quality metrics sector we will be able to see what is already in place and steps we will undertake that will be beneficial for physicians.

Detailed description: This is a prospective study to evaluate performance of disposable TIP duodenoscopes. Scope is designed to facilitate effective reprocessing of duodenoscope and thus prevent future outbreaks related to contaminated duodenoscope despite standard reprocessing.

This is a multi-center study being performed at the University of Texas Health Science Center, Wake Forest Baptist Health and Institute of Gastroenterology in Ecuador. The study will enroll a total of 100 patients who undergo ERCP. The study is purely observational as it will collect clinical success and information of the TIP duodenoscope.

Eligibility criteria: Inclusion Criteria:

* Any adult patients undergoing ERCP.
* Patient has a clinical indication for ERCP.

Exclusion Criteria:

* Any patients less than 18 years old undergoing ERCP as medical necessary procedure.
* Patients who refuse to consent for ERCP procedure.

Primary outcomes:
measure: Disposable TIP duodenoscope survey evaluation performance
timeFrame: During procedure
measure: To get insight from end-users such as physicians, fellows in training and nurse technicians regarding the disposable TIP duodenoscope performance during various steps of ERCP procedure through a questionnaire provided.
timeFrame: during procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Nirav Thosani, MD, MHA
role: PRINCIPAL_INVESTIGATOR
References: