ERCPdeCAPNCT04447976
Prospective Evaluation of Performance of Disposable Elevator Cap Duodenoscope During ERCP in Clinical Practice
An observational study of ERCP, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- ERCP
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2020to Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Any adult patients undergoing ERCP.
- Patient has a clinical indication for ERCP.
Who cannot join
- Any patients less than 18 years old undergoing ERCP as medical necessary procedure.
- Patients who refuse to consent for ERCP procedure.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Memorial Hermann Hospital
Houston, Texas, 77030
Prithvi Patil, MS, 713-500-6456, prithvi.b.patil@uth.tmc.edu
About this study
Official title: A Multi-center Prospective Study to Evaluate Performance of Disposable TIP Duodenoscope Designed to Prevent Future Outbreak Related to Contaminated Duodenoscope.
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
Read more
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.
Read the 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.
- Conditions
- ERCP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing ERCP by formally trained Endoscopists | No intervention has been used and this is an observational study of evaluation of a TIP duodenoscope performance overall. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disposable TIP duodenoscope survey evaluation performance
To evaluate overall performance of disposable TIP duodenoscope through a survey regarding its performance during various steps of ERCP procedure.
Measured: During procedure
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.
To evaluate overall performance of disposable TIP duodenoscopes through a survey and get insight from end-users such as physicians, fellows in training and nurse technicians regarding its performance during various steps of ERCP procedure.
Measured: during procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start2 Jun 2020
- Primary completionOct 2021 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ERCPStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Wake Forest University Health Sciences, Instituto Ecuatoriano de Enfermedades Digestivas
- Responsible party
- Principal investigator, Nirav C Thosani, The University of Texas Health Science Center, Houston
- Investigators
- Nirav Thosani, MD, MHA, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04447976
- Sponsor's protocol ID
- HSC-MS-20-0408
- Acronym
- deCAP
- Status last verified
- Jan 2021
- First submitted
- 11 Jun 2020
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Prospective Study to Evaluate Performance of Disposable TIP Duodenoscope Designed to Prevent Future Outbreak Related to Contaminated Duodenoscope.
- ClinicalTrials.gov ID
- NCT04447976
- Acronym / sponsor ID
- deCAP / HSC-MS-20-0408
- Conditions
- ERCP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Wake Forest University Health Sciences, Instituto Ecuatoriano de Enfermedades Digestivas
- Study start
- 2 Jun 2020 (actual)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 25 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing ERCP by formally trained Endoscopists | – | –No intervention has been used and this is an observational study of evaluation of a TIP duodenoscope performance overall. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Any adult patients undergoing ERCP.
- Patient has a clinical indication for ERCP.
Key exclusion criteria (2 listed)
- Any patients less than 18 years old undergoing ERCP as medical necessary procedure.
- Patients who refuse to consent for ERCP procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disposable TIP duodenoscope survey evaluation performance
Time frame: During procedure
To evaluate overall performance of disposable TIP duodenoscope through a survey regarding its performance during various steps of ERCP procedure.
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.
Time frame: during procedure
To evaluate overall performance of disposable TIP duodenoscopes through a survey and get insight from end-users such as physicians, fellows in training and nurse technicians regarding its performance during various steps of ERCP procedure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nirav Thosani, MD, MHA principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ERCP, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Prithvi Patil, MS (713-500-6456, prithvi.b.patil@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disposable TIP duodenoscope survey evaluation performance (time frame: During procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2021.