NCT04371354

Brief Summary

Prospective study evaluating the outcomes of implementation of a protective protocol for Covid-19 for patients and staff in a large endoscopy unit.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

April 27, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 28, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 1, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2021

Completed
Last Updated

September 8, 2021

Status Verified

August 1, 2021

Enrollment Period

1.1 years

First QC Date

April 28, 2020

Last Update Submit

August 31, 2021

Conditions

Covid-19 DiseaseEndoscopy Unit

Keywords

Covid-19 diseaseendoscopygastrointestinalpersonal protective equipment

Outcome Measures

Primary Outcomes (1)

  • Rate of new Covid infection of patients and staff members

    Number of new Covid infection of patients and staff members

    3 months

Secondary Outcomes (3)

  • Covid disease prevalence in the patients referred to endoscopy

    3 months

  • Categorization by clinical triage and Covid Test

    3 months

  • Type of endoscopy procedure and staff protective equipment

    3 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing an endoscopic procedure

You may qualify if:

  • patients undergoing an endoscopic procedure with written informed consent given.
  • Staff allocated in the endoscopy unit.

You may not qualify if:

  • Refection to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Complejo Hospitalario de Navarra

Pamplona, Navarre, 31008, Spain

Location

Study Officials

  • Juan J Vila, PhD

    Tertiary referral hospital: Complejo Hospitalario de Navarra. Pamplona.Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor, University of Navarra associate professor

Study Record Dates

First Submitted

April 28, 2020

First Posted

May 1, 2020

Study Start

April 27, 2020

Primary Completion

June 14, 2021

Study Completion

December 27, 2021

Last Updated

September 8, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)