Single-use Versus Reusable Gastroscopes in Patients With Upper Gastrointestinal Bleeding. (OneScopeII)

January 29, 2024 updated by: University Hospital Augsburg

One-Scope II: Single-use Versus Reusable Gastroscopes in Patients With Upper Gastrointestinal Bleeding.

Controlled-randomized trial evaluating single-use versus reusable gastroscopes in patients with upper gastrointestinal bleeding.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Acute upper gastrointestinal bleeding is a common medical emergency. According to guidelines, endoscopic evaluation should be performed within 24 hours. With an overall high incidence and an overall high number of diagnostic and therapeutic endoscopic procedures, the introduction of new endoscopic concepts may have a profound impact on outcomes as well as cost-effectiveness in upper gastrointestinal bleeding. For this purpose, the use of single-use gastroscopes represents an interesting possibility. Hygiene issues in the emergency situation are also relevant. The previous feasibility study One-Scope I demonstrated that the diagnosis as well as the therapy of upper gastrointestinal bleeding is possible with single-use gastroscopes. In this follow-up study, the investigators compare the use of single-use versus reusable gastroscopes in participants with suspected upper gastrointestinal bleeding in a randomized controlled trial.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Germany
    • Bavaria
      • Augsburg, Bavaria, Germany, 86156
        • Recruiting
        • University Hospital of Augsburg
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christoph Römmele, MD
        • Sub-Investigator:
          • Alanna Ebigbo, MD
        • Sub-Investigator:
          • Vidan Tadic, MD
        • Sub-Investigator:
          • Helmut Messmann, MD
        • Sub-Investigator:
          • Mousa Ayoub, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Glasgow-Blatchford score (GBS) >2
  • Clinical signs of upper bleeding

Exclusion Criteria:

  • pregnancy
  • Unable to provide consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Single-use gastroscope
A disposable endoscope designed for a one-time use during a Gastroscopy, eliminating the need for reprocessing or sterilization. After a single procedure, the entire gastroscope is discarded, reducing the risk of cross-contamination and ensuring a fresh, sterile instrument for each patient intervention
Device: Endoscopic hemostasis using a Esophagogastroduodenoscopy
performing an Esophagogastroduodenoscopy for diagnosis and therapy of possible bleeding sites
Active Comparator: reusable gastroscope
A durable endoscope designed for multiple uses after thorough reprocessing and sterilization
Device: Endoscopic hemostasis using a Esophagogastroduodenoscopy
performing an Esophagogastroduodenoscopy for diagnosis and therapy of possible bleeding sites

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
intraprocedural technical success
Time Frame: Up to 20 minutes
defined as reaching the descending duodenum and adequately assessing for the presence of a bleeding site
Up to 20 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
intraprocedural clinical success
Time Frame: Up to 45 Minutes
defined as successful endoscopic hemostasis during the examination if required
Up to 45 Minutes
re-bleeding rate
Time Frame: Up to 30 days
need for further endoscopic, interventional-angiographic, or surgical intervention within 30 days due to upper GI-bleeding
Up to 30 days
blood transfusions
Time Frame: Up to 30 days
Need for blood transfusion due to a hemorrhage-related decrease in hemoglobin levels ≤ 70 g/L
Up to 30 days
Length of Stay
Time Frame: Up to 30 days
Duration of inpatient stay, measured from the day of admission to the day of discharge
Up to 30 days
Length of intervention
Time Frame: Up to 60 minutes
measured from initiation to achievement of hemostasis
Up to 60 minutes
cross over to reusable gastroscope
Time Frame: Up to 60 Minutes
Switch to a reusable gastroscope in case of non-achieved technical or clinical success, such as unsuccessful hemostasis, insufficient assessment of the bleeding source, or inability to reach the descending duodenum
Up to 60 Minutes
Adverse events
Time Frame: Up to 30 days
Occurrence of adverse events, such as perforation, bleeding exacerbation, aspiration, and infection.
Up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital Augsburg

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christoph Römmele, MD, Unervsity Hospital Augsburg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 27, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 12, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 31, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 00000013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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