Bleeding Peptic UlcerOTSCvsTTSNCT03551262
Over-the-scope Clip Versus Through-the-scope Clip for Endoscopic Hemostasis of High Risk Bleeding Peptic Ulcers
A study testing OTSC and TTS clip in people with Bleeding Peptic Ulcer, run by Azienda USL Modena at 1 site in Italy.
Trial summary
To compare in a multicenter, prospective, randomized, controlled trial the efficacy and safety of OTSC versus TTS clip for first-line hemostasis of high risk bleeding peptic ulcers Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bleeding Peptic Ulcer
- What is being tested?
- OTSC and TTS clip
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteItaly
- Study dates
- 26 Oct 2018to 26 Oct 2023
- 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
- patients with suspected NVUGIB and subsequent endoscopic finding of peptic ulcer (Ia-IIb according to Forrest classification)
- age ≥ 18 years
Who cannot join
- patients who refused to participate at the trial
- pregnancy
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda USL Modena
Carpi, Modena, 41012
Paola Soriani, MD, 00039059659250, p.soriani@ausl.mo.it
About this study
To compare in a multicenter, prospective, randomized, controlled trial the efficacy and safety of OTSC versus TTS clip for first-line hemostasis of high risk bleeding peptic ulcers
Read the detailed description
Despite major advances in the management of non-variceal upper gastrointestinal bleeding (NVUGIB) over the past decade including prevention of peptic ulcer bleeding, optimal use of endoscopic therapy and high-dose proton pump inhibition, this still carries considerable morbidity, mortality and health economic burden Of particular note are the re-bleeding rates, one of the most crucial predictive factors of morbidity and mortality that has not significantly improved as evident from longitudinal data in the past 15 years Although huge advances have been made in terms of therapeutic endoscopic devices available today, complete haemostasis of complicated lesions (i.e. severe bleeding from large vessels or fibrotic ulcer) still remains a challenge and can be difficult to achieve. In particular, traditional clipping devices often appear technically difficult to place and insufficient to provide adequate tissue compression to obliterate large bleeding vessels.
The over-the-scope clip (OTSC) (Ovesco Endoscopy AG, Tubingen, Germany) system is a recently developed endoscopic device. In a preliminary experience, it has been successfully used in patients with severe bleeding or deep wall lesions, or perforations of the GI tract.
Recent retrospectives studies have demonstrated the efficacy and safety of OTSC in patients undergoing emergency endoscopy for severe acute NVUGIB after failure of conventional techniques and as first-line To the best of the investigator's knowledge, no randomized clinical trial have been performed investigating the use of OTSC as first-line endoscopic treatment in patients with high-risk NVUGIB.
- Conditions
- Bleeding Peptic Ulcer
- Being tested
- OTSC, TTS clip
- Medical subject headings
- Peptic Ulcer Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTSCDevice
Positioning of OTSC in bleeding peptic ulcer
TTS clipDevice
Positioning of TTS clip in bleeding peptic ulcer
| Study group | Role | What they receive |
|---|---|---|
| OTSC | Experimental | Use of OTSC to treat high-risk peptic ulcers (gastric and duodenal), i.e. Forrest Ia, Ib, IIa, IIb, in first-line endoscopic haemostatic treatment. Receives: Device: OTSC |
| TTS clip | Active comparator | Use of TTS clip to treat high-risk peptic ulcers (gastric and duodenal), i.e. Forrest Ia, Ib, IIa, IIb in first-line endoscopic haemostatic treatment Receives: Device: TTS clip |
What is being measured
The primary outcome is the main question the study is designed to answer.
successful haemostasis rate
defined as the absence of bleeding upon at least one minute observation after the assigned endoscopic therapy
Measured: during the EGDS
30-day rebleeding
re-bleeding episodes (per patient), after the primary endoscopic hemostatic treatment, defined as one or more of the following signs:
- hematemesis
- presence of fresh blood in the nasogastric tube
- hemodynamic instability (pulse and blood pressure)
- reduction of Hb by more than 2 g/dL over a 24 h period (early recurrence) or over a 7 days period (late recurrence) after initial stabilization
Measured: up to 30 days
overall clinical success
defined as successful homeostasis rate without evidence of 30-day rebleeding
Measured: up to 30 days
Secondary outcomes (5)
mortality
number of patients dead with no more rebleeding episodes and number of patients dead with rebleeding episodes, despite the endoscopic treatment
Measured: up to 30 days
lenght of hospital stay
number of days during the hospital stay
Measured: up to 30 days
transfusion requirements
number of transfunsions needed
Measured: up to 30 days
need for radiology
further radiological procedure because of the previous endoscopic failure
Measured: up to 30 days
need for surgery
further surgical procedure because of the previous endoscopic and radiological failures
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 posted11 Jun 2018
- Study start26 Oct 2018
- Primary completion26 Oct 2023 (estimated)
- Study completion26 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bleeding Peptic UlcerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, prospective, randomized, controlled
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda USL Modena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Mauro Manno, Azienda USL Modena
- Investigators
- Mauro Manno, MD, Principal investigator, Digestive Endoscopy Unit, Northen Area, AUSL Modena (Italy)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03551262
- Sponsor's protocol ID
- 01-2017
- Acronym
- OTSCvsTTS
- Status last verified
- Jul 2022
- First submitted
- 13 Oct 2017
- Last updated
- 6 May 2023
- 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 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Over-the-scope Clip Versus Through-the-scope Clip for Endoscopic Hemostasis of High Risk Bleeding Peptic Ulcers
- ClinicalTrials.gov ID
- NCT03551262
- Acronym / sponsor ID
- OTSCvsTTS / 01-2017
- Conditions
- Bleeding Peptic Ulcer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Azienda USL ModenaUniversity, hospital or other
- Study start
- 26 Oct 2018 (actual)
- Primary completion
- 26 Oct 2023 (estimated)
- Study completion
- 26 Oct 2023 (estimated)
- First posted
- 11 Jun 2018 (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.
To compare in a multicenter, prospective, randomized, controlled trial the efficacy and safety of OTSC versus TTS clip for first-line hemostasis of high risk bleeding peptic ulcers
Detailed description
Despite major advances in the management of non-variceal upper gastrointestinal bleeding (NVUGIB) over the past decade including prevention of peptic ulcer bleeding, optimal use of endoscopic therapy and high-dose proton pump inhibition, this still carries considerable morbidity, mortality and health economic burden Of particular note are the re-bleeding rates, one of the most crucial predictive factors of morbidity and mortality that has not significantly improved as evident from longitudinal data in the past 15 years Although huge advances have been made in terms of therapeutic endoscopic devices available today, complete haemostasis of complicated lesions (i.e. severe bleeding from large vessels or fibrotic ulcer) still remains a challenge and can be difficult to achieve. In particular, traditional clipping devices often appear technically difficult to place and insufficient to provide adequate tissue compression to obliterate large bleeding vessels.
The over-the-scope clip (OTSC) (Ovesco Endoscopy AG, Tubingen, Germany) system is a recently developed endoscopic device. In a preliminary experience, it has been successfully used in patients with severe bleeding or deep wall lesions, or perforations of the GI tract.
Recent retrospectives studies have demonstrated the efficacy and safety of OTSC in patients undergoing emergency endoscopy for severe acute NVUGIB after failure of conventional techniques and as first-line To the best of the investigator's knowledge, no randomized clinical trial have been performed investigating the use of OTSC as first-line endoscopic treatment in patients with high-risk NVUGIB.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter, prospective, randomized, controlled
| Arm | Type | Receives |
|---|---|---|
| OTSC | Experimental | Device: OTSCUse of OTSC to treat high-risk peptic ulcers (gastric and duodenal), i.e. Forrest Ia, Ib, IIa, IIb, in first-line endoscopic haemostatic treatment. |
| TTS clip | Active comparator | Device: TTS clipUse of TTS clip to treat high-risk peptic ulcers (gastric and duodenal), i.e. Forrest Ia, Ib, IIa, IIb in first-line endoscopic haemostatic treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with suspected NVUGIB and subsequent endoscopic finding of peptic ulcer (Ia-IIb according to Forrest classification)
- age ≥ 18 years
Key exclusion criteria (2 listed)
- patients who refused to participate at the trial
- pregnancy
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 |
|---|---|---|
| OTSCPositioning of OTSC in bleeding peptic ulcer | Device | OTSC |
| TTS clipPositioning of TTS clip in bleeding peptic ulcer | Device | TTS clip |
Primary outcome
successful haemostasis rate
Time frame: during the EGDS
defined as the absence of bleeding upon at least one minute observation after the assigned endoscopic therapy
30-day rebleeding
Time frame: up to 30 days
re-bleeding episodes (per patient), after the primary endoscopic hemostatic treatment, defined as one or more of the following signs: * hematemesis * presence of fresh blood in the nasogastric tube * hemodynamic instability (pulse and blood pressure) * reduction of Hb by more than 2 g/dL over a 24 h period (early recurrence) or over a 7 days period (late recurrence) after initial stabilization
overall clinical success
Time frame: up to 30 days
defined as successful homeostasis rate without evidence of 30-day rebleeding
5 secondary outcomes
mortality
Time frame: up to 30 days
lenght of hospital stay
Time frame: up to 30 days
transfusion requirements
Time frame: up to 30 days
need for radiology
Time frame: up to 30 days
need for surgery
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 6 May 2023.
- 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.
Mauro Manno, MD principal investigator
Digestive Endoscopy Unit, Northen Area, AUSL Modena (Italy)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OTSC and TTS clip in people with Bleeding Peptic Ulcer, run by Azienda USL Modena at 1 site in Italy.
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 6 May 2023. 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 Italy. 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 Mauro Manno, MD (+39059659250, m.manno@ausl.mo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
successful haemostasis rate (time frame: during the EGDS). The study lists 3 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 6 May 2023.