Upper Gastrointestinal BleedingOneScopeIINCT06192355
Single-use Versus Reusable Gastroscopes in Patients With Upper Gastrointestinal Bleeding.
A study testing Endoscopic hemostasis using a Esophagogastroduodenoscopy in people with Upper Gastrointestinal Bleeding, run by University Hospital Augsburg at 1 site in Germany.
Trial summary
Controlled-randomized trial evaluating single-use versus reusable gastroscopes in patients with upper gastrointestinal bleeding. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Gastrointestinal Bleeding
- What is being tested?
- Endoscopic hemostasis using a Esophagogastroduodenoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- 27 Mar 2023to 1 Jan 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Glasgow-Blatchford score (GBS) >2
- Clinical signs of upper bleeding
Who cannot join
- pregnancy
- Unable to provide consent
Trial locations and contacts
1 site in 1 country.
Alanna Ebigbo, MD contact
Germany1 site, 1 recruiting
- Recruiting
University Hospital of Augsburg
Augsburg, Bavaria, 86156
Christoph Römmele, MD, +498214002351, christoph.roemmele@uk-augsburg.de
Alanna Ebigbo, MD, alanna.ebigbo@uk-augsburg.de
About this study
Official title: 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.
Read the 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.
- Conditions
- Upper Gastrointestinal Bleeding
- Being tested
- Endoscopic hemostasis using a Esophagogastroduodenoscopy
- Keywords
- Endoscopy, Emergency
- Medical subject headings
- Gastrointestinal Hemorrhage, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic hemostasis using a EsophagogastroduodenoscopyDevice
performing an Esophagogastroduodenoscopy for diagnosis and therapy of possible bleeding sites
| Study group | Role | What they receive |
|---|---|---|
| Single-use gastroscope | Experimental | 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 Receives: Device: Endoscopic hemostasis using a Esophagogastroduodenoscopy |
| reusable gastroscope | Active comparator | A durable endoscope designed for multiple uses after thorough reprocessing and sterilization Receives: Device: Endoscopic hemostasis using a Esophagogastroduodenoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraprocedural technical success
defined as reaching the descending duodenum and adequately assessing for the presence of a bleeding site
Measured: Up to 20 minutes
Secondary outcomes (7)
intraprocedural clinical success
defined as successful endoscopic hemostasis during the examination if required
Measured: Up to 45 Minutes
re-bleeding rate
need for further endoscopic, interventional-angiographic, or surgical intervention within 30 days due to upper GI-bleeding
Measured: Up to 30 days
blood transfusions
Need for blood transfusion due to a hemorrhage-related decrease in hemoglobin levels ≤ 70 g/L
Measured: Up to 30 days
Length of Stay
Duration of inpatient stay, measured from the day of admission to the day of discharge
Measured: Up to 30 days
Length of intervention
measured from initiation to achievement of hemostasis
Measured: Up to 60 minutes
cross over to reusable gastroscope
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
Measured: Up to 60 Minutes
Adverse events
Occurrence of adverse events, such as perforation, bleeding exacerbation, aspiration, and infection.
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start27 Mar 2023
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Gastrointestinal BleedingStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Augsburg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph Römmele, MD, Principal investigator, Unervsity Hospital Augsburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06192355
- Sponsor's protocol ID
- 00000013
- Acronym
- OneScopeII
- Status last verified
- Jan 2024
- First submitted
- 12 May 2023
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-Scope II: Single-use Versus Reusable Gastroscopes in Patients With Upper Gastrointestinal Bleeding.
- ClinicalTrials.gov ID
- NCT06192355
- Acronym / sponsor ID
- OneScopeII / 00000013
- Conditions
- Upper Gastrointestinal Bleeding
- Keywords
- Endoscopy, Emergency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital AugsburgUniversity, hospital or other
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 5 Jan 2024 (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.
Controlled-randomized trial evaluating single-use versus reusable gastroscopes in patients with upper gastrointestinal bleeding.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-use gastroscope | Experimental | Device: Endoscopic hemostasis using a EsophagogastroduodenoscopyA 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 |
| reusable gastroscope | Active comparator | Device: Endoscopic hemostasis using a EsophagogastroduodenoscopyA durable endoscope designed for multiple uses after thorough reprocessing and sterilization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Glasgow-Blatchford score (GBS) >2
- Clinical signs of upper bleeding
Key exclusion criteria (2 listed)
- pregnancy
- Unable to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic hemostasis using a Esophagogastroduodenoscopyperforming an Esophagogastroduodenoscopy for diagnosis and therapy of possible bleeding sites | Device | Single-use gastroscope, reusable gastroscope |
Primary outcome
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
7 secondary outcomes
intraprocedural clinical success
Time frame: Up to 45 Minutes
re-bleeding rate
Time frame: Up to 30 days
blood transfusions
Time frame: Up to 30 days
Length of Stay
Time frame: Up to 30 days
Length of intervention
Time frame: Up to 60 minutes
cross over to reusable gastroscope
Time frame: Up to 60 Minutes
Adverse events
Time frame: Up to 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Alanna Ebigbo, MD contact
Christoph Römmele, MD principal investigator
Unervsity Hospital Augsburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic hemostasis using a Esophagogastroduodenoscopy in people with Upper Gastrointestinal Bleeding, run by University Hospital Augsburg at 1 site in Germany.
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 31 Jan 2024. 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 Germany. 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 Christoph Römmele, MD (+498214002351, christoph.roemmele@uk-augsburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraprocedural technical success (time frame: Up to 20 minutes). 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 31 Jan 2024.