---
title: Outcomes of Covid-19 Protective Measures in Endoscopy
nct_id: NCT04371354
overall_status: UNKNOWN
sponsor: Fundacion Miguel Servet
study_type: OBSERVATIONAL
primary_condition: Covid-19 Disease
countries: Spain
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04371354.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04371354"
ct_last_update_post_date: 2021-09-08
last_seen_at: "2026-05-12T07:06:59.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Outcomes of Covid-19 Protective Measures in Endoscopy

**Official Title:** Outcomes After Implementation of a Protective Protocol for Covid-19 in Large Spanish Endoscopy Units.

**NCT ID:** [NCT04371354](https://clinicaltrials.gov/study/NCT04371354)

## Key Facts

- **Status:** UNKNOWN
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 100
- **Lead Sponsor:** Fundacion Miguel Servet
- **Conditions:** Covid-19 Disease, Endoscopy Unit
- **Start Date:** 2020-04-27
- **Completion Date:** 2021-12-27
- **CT.gov Last Update:** 2021-09-08

## 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.

## Detailed Description

Detailed description: SARS-Covid-19 virus pandemic has had a big impact both socially and on operation of health facilities. During the Covid-19 outbreak most of the scheduled endoscopies were cancelled and only emergent and urgent endoscopies were performed in the unit. This meant that for six weeks, around 98% of our daily workload was cancelled. During that time the investigators have developed a protocol in order to resume scheduled endoscopic activity in the decreasing phase of the pandemic.

The hypothesis of this prospective observational study is that implementation of a protocol based upon Covid PCR tests and clinical triage is useful to categorize two types of Covid-19 infection risk and two levels of personal protection equipments required.

The primary aim is to evaluate the outcomes of implementing a protective protocol with two levels of protection for Covid-19 in the endoscopy unit. As secondary aims, the investigators, want to evaluate the endoscopy unit staff and patients infection rate after implementation of the protective protocol; and the utility of previous Covid PCR testing and on day clinical triage to discriminate patients before endoscopy.

A brief daily questionnaire will be filled by all the endoscopy unit staff members questioning about type of procedures performed in their allocated endoscopy room, level of protection used and PCR status of their attended patients. Patients will be followed up for a period of two weeks to discard development of Covid-19 disease with possible origin in their visit to the endoscopy unit.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

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

Exclusion Criteria:

* Refection to participate in the study.
```

## Primary Outcomes

- **Rate of new Covid infection of patients and staff members** _(time frame: 3 months)_ — Number of new Covid infection of patients and staff members

## Secondary Outcomes

- **Covid disease prevalence in the patients referred to endoscopy** _(time frame: 3 months)_
- **Categorization by clinical triage and Covid Test** _(time frame: 3 months)_
- **Type of endoscopy procedure and staff protective equipment** _(time frame: 3 months)_

## Locations (1)

- Complejo Hospitalario de Navarra, Pamplona, Navarre, Spain

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.complejo hospitalario de navarra|pamplona|navarre|spain` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04371354.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04371354*  
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