Cap-assisted EndoscopyCAPNCT07268365
Is Cap Assisted Endoscopy Useful in Acute Upper Gastrointestinal Bleeding ?
A study testing upper endoscopy and CAP in people with Cap-assisted Endoscopy and Upper Gastro Intestinal Bleeding, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
High digestive bleeding (HDH) is a medical emergency associated with high morbidity and mortality rates and significant healthcare costs. Upper endoscopy can locate the bleeding and treat it. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cap-assisted Endoscopy, Upper Gastro Intestinal Bleeding, Endoscopy
- What is being tested?
- upper endoscopy and CAP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- 16 Oct 2025to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patient > 18 years old
- Upper GI bleeding suspected in presence of melena or hematemesis
- Glasgow Blatchford score > 8
- Upper gastroscopy at Amiens University Hospital
- Follow-up at Amiens university hospital
- Presence of gastric or duodenal ulcer requiring endoscopic hemostasis (FORREST Ia, Ib, IIa, IIb)
- No opposition to the study
- No guardianship or curators
Who cannot join
- Patient with clinical suspicion of portal hypertension
- Known liver failure
- Patient with digestive hemorrhage related to a lesion located beyond the 2nd duodenum
- Patient with digestive hemorrhage related to a varicose lesion (esophageal or gastric varices)
- Patient with bleeding associated with esophagitis
- Patient with bleeding associated with angiodysplasias
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire d'Amiens
Amiens, Picardie, 80000
Clara Yzet, MD, 03 22 08 88 50, yzet.clara@chu-amiens.fr
About this study
High digestive bleeding (HDH) is a medical emergency associated with high morbidity and mortality rates and significant healthcare costs. Upper endoscopy can locate the bleeding and treat it. However, the source of bleeding can be difficult to identify, even for the most experienced endoscopists, due to the location of the bleeding (posterior wall of the bulb, gastric or duodenal folds, papillary region, esophagogastric junction), instability of the tube due to gastric and pyloric contractions and respiratory movements, leading to longer procedure times, hemostasis failure, or even the absence of bleeding visualization. The use of a cap attached to the endoscope facilitates exploration of blind areas of the colonic mucosa located behind folds, thus reducing the rate of missed polyps and cecal intubation time. To date, there is no study evaluating the systematic use of a cap in patients with suspected high digestive bleeding. A series of four cases demonstrated its benefit, allowing for better exposure of the bleeding lesion, better unfolding of intestinal folds, and thus a more effective and quicker hemostatic treatment.
- Being tested
- upper endoscopy, CAP
- Keywords
- Cap-assisted endoscopy, upper gastro intestinal bleeding, endoscopy
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
upper endoscopyProcedure or surgery
All patients with the inclusion criteria will be randomized (randomization 1:1) to undergo either an upper endoscopy with an endoscopic cap or without a cap
CAPProcedure or surgery
All patients with the inclusion criteria will be randomized (randomization 1:1) to undergo either an upper endoscopy with an endoscopic cap or without a cap
| Study group | Role | What they receive |
|---|---|---|
| standard upper endoscopy | Active comparator | standard upper endoscopy Receives: Procedure: upper endoscopy |
| CAP | Experimental | upper endoscopy with the placement of an endoscopic cap Receives: Procedure: upper endoscopy; Procedure: CAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
procedure time until endoscopic hemostasis is achieved
procedure time until endoscopic hemostasis is achieved
Measured: 1 month
Secondary outcomes (7)
therapeutic success rate
therapeutic success rate
Measured: 1 month
clinical success rate
clinical success rate
Measured: 1 month
time until bleeding localization
time until bleeding localization
Measured: up to 1 month
duration of hemostasis achievement
duration of hemostasis achievement
Measured: up to 1 month
endoscope stability
assessment of endoscopist satisfaction in terms of endoscope stability
Measured: up to 1 month
lesion visualization
lesion visualization
Measured: up to 1 month
hemostasis
hemostasis
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start16 Oct 2025
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cap-assisted EndoscopyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07268365
- Sponsor's protocol ID
- PI2025_843_0158
- Acronym
- CAP
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 5 Dec 2025
- 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 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Cap Assisted Endoscopy Useful in Acute Upper Gastrointestinal Bleeding ?
- ClinicalTrials.gov ID
- NCT07268365
- Acronym / sponsor ID
- CAP / PI2025_843_0158
- Keywords
- Cap-assisted endoscopy, upper gastro intestinal bleeding, endoscopy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 16 Oct 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 5 Dec 2025 (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.
High digestive bleeding (HDH) is a medical emergency associated with high morbidity and mortality rates and significant healthcare costs. Upper endoscopy can locate the bleeding and treat it. However, the source of bleeding can be difficult to identify, even for the most experienced endoscopists, due to the location of the bleeding (posterior wall of the bulb, gastric or duodenal folds, papillary region, esophagogastric junction), instability of the tube due to gastric and pyloric contractions and respiratory movements, leading to longer procedure times, hemostasis failure, or even the absence of bleeding visualization. The use of a cap attached to the endoscope facilitates exploration of blind areas of the colonic mucosa located behind folds, thus reducing the rate of missed polyps and cecal intubation time. To date, there is no study evaluating the systematic use of a cap in patients with suspected high digestive bleeding. A series of four cases demonstrated its benefit, allowing for better exposure of the bleeding lesion, better unfolding of intestinal folds, and thus a more effective and quicker hemostatic treatment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard upper endoscopy | Active comparator | Procedure: upper endoscopystandard upper endoscopy |
| CAP | Experimental | Procedure: upper endoscopy, Procedure: CAPupper endoscopy with the placement of an endoscopic cap |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient > 18 years old
- Upper GI bleeding suspected in presence of melena or hematemesis
- Glasgow Blatchford score > 8
- Upper gastroscopy at Amiens University Hospital
- Follow-up at Amiens university hospital
Key exclusion criteria (6 listed)
- Patient with clinical suspicion of portal hypertension
- Known liver failure
- Patient with digestive hemorrhage related to a lesion located beyond the 2nd duodenum
- Patient with digestive hemorrhage related to a varicose lesion (esophageal or gastric varices)
- Patient with bleeding associated with esophagitis
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 |
|---|---|---|
| upper endoscopyAll patients with the inclusion criteria will be randomized (randomization 1:1) to undergo either an upper endoscopy with an endoscopic cap or without a cap | Procedure or surgery | CAP, standard upper endoscopy |
| CAPAll patients with the inclusion criteria will be randomized (randomization 1:1) to undergo either an upper endoscopy with an endoscopic cap or without a cap | Procedure or surgery | CAP |
Primary outcome
procedure time until endoscopic hemostasis is achieved
Time frame: 1 month
procedure time until endoscopic hemostasis is achieved
7 secondary outcomes
therapeutic success rate
Time frame: 1 month
clinical success rate
Time frame: 1 month
time until bleeding localization
Time frame: up to 1 month
duration of hemostasis achievement
Time frame: up to 1 month
endoscope stability
Time frame: up to 1 month
lesion visualization
Time frame: up to 1 month
hemostasis
Time frame: up to 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing upper endoscopy and CAP in people with Cap-assisted Endoscopy and Upper Gastro Intestinal Bleeding, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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 8 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 5 Dec 2025. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clara YZET, MD (33+3 22 08 88 50, yzet.clara@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
procedure time until endoscopic hemostasis is achieved (time frame: 1 month). 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 5 Dec 2025.