Duodenal BleedingPURASTATNCT05746884
Haemostatic Gel Prophylaxis for Post Duodenal Endoscopic Resection Bleeding
A study testing duodenal mucosectomy and ampullectomy in people with Duodenal Bleeding, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
The purpose of this study is to test whether prophylactic application of haemostatic gel will reduce the rate of clinically significant bleeding requiring intervention (such as blood transfusion, admission to hospital, other blood products) following endoscopic resection of advanced duodenal neoplasia compared to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Duodenal Bleeding
- What is being tested?
- duodenal mucosectomy and ampullectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteFrance
- Study dates
- 21 Aug 2023to 5 Nov 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
- Ampullary lesions
- Single ampullary lesion ≥ 10mm
- Resection via hot ampullectomy, injection/Endoscopic mucosal resection of adjacent lateral spreading component Duodenal Lesions
- ≤ 2 lesions
- Lesion ≥15mm
- Resection via hot Endoscopic mucosal resection
- Morphology: 0-Is, 0-IIa/b/c or combination, submucosal lesions
Who cannot join
- Inability to provide informed consent (including people with cognitive impairment);
- Pregnant or breastfeeding women;
- Allergy to PuraStat®;
- "Cold" mucosal endoscopic resection;
- Patient under guardianship or curatorship, or under a regime of deprivation of liberty;
- Participating patient, or in a period of exclusion from another clinical trial;
- Patient not benefiting from a social security scheme.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to test whether prophylactic application of haemostatic gel will reduce the rate of clinically significant bleeding requiring intervention (such as blood transfusion, admission to hospital, other blood products) following endoscopic resection of advanced duodenal neoplasia compared to standard therapy.
Read the detailed description
This is a post-marketing follow-up study of a CE marked medical device, controlled, comparative, randomized, multicentre, international single-blind.
The main objective is to evaluate the efficacy and safety of PuraStat in duodenal endoscopic mucosal resection or ampullectomy.
This study will be carried out in France in 3 investigative centers. The duration of patient participation in the study is approximately 37 days depending on the time between the selection and the endoscopic intervention.
- Conditions
- Duodenal Bleeding
- Being tested
- duodenal mucosectomy, ampullectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
duodenal mucosectomyProcedure or surgery
Standard resection technique will be performed for duodenal mucosectomy, as well as the usual hemostasis at the discretion of the operator.
ampullectomyProcedure or surgery
Standard resection technique will be performed for ampullectomy, as well as the usual hemostasis at the discretion of the operator.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group with PuraStat® | Experimental | Endoscopic mucosectomy or endoscopic ampullectomy with standard resection technique, per-procedure hemostasis at operator discretion and application of PuraStat® Receives: Procedure: duodenal mucosectomy; Procedure: ampullectomy |
| Control Group | Active comparator | Endoscopic mucosectomy or endoscopic ampullectomy with standard resection technique, per-procedural hemostasis at operator discretion Receives: Procedure: duodenal mucosectomy; Procedure: ampullectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding rate requiring further intervention within 30 days
Rate of clinically significant delayed postoperative bleeding requiring further intervention within 30 days (such as blood transfusion, packed cell transfusion or administration of other blood products, hospitalization or repeat endoscopy)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start21 Aug 2023
- Primary completion5 Nov 2025
- Study completion5 Nov 2025
Why it stopped: The sponsor, in consultation with the research team, has decided to terminate the study early. Unfortunately, there have been no new enrollments since October 2025.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duodenal 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-blind, controlled, comparative, randomized, multicentre, international post-marketing follow-up study of a CE marked medical device.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la Recherche
- Sponsor type
- University, hospital or other
- Collaborators
- Euraxi Pharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746884
- Sponsor's protocol ID
- 2022-A02660-43
- Acronym
- PURASTAT
- Status last verified
- Oct 2026
- First submitted
- 13 Feb 2023
- Last updated
- 27 Oct 2026
- 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 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haemostatic Gel Prophylaxis for Post Duodenal Endoscopic Resection Bleeding
- ClinicalTrials.gov ID
- NCT05746884
- Acronym / sponsor ID
- PURASTAT / 2022-A02660-43
- Conditions
- Duodenal Bleeding
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The sponsor, in consultation with the research team, has decided to terminate the study early. Unfortunately, there have been no new enrollments since October 2025.
- Enrolment
- 67 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- Euraxi Pharma
- Study start
- 21 Aug 2023 (actual)
- Primary completion
- 5 Nov 2025 (actual)
- Study completion
- 5 Nov 2025 (actual)
- First posted
- 28 Feb 2023 (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.
The purpose of this study is to test whether prophylactic application of haemostatic gel will reduce the rate of clinically significant bleeding requiring intervention (such as blood transfusion, admission to hospital, other blood products) following endoscopic resection of advanced duodenal neoplasia compared to standard therapy.
Detailed description
This is a post-marketing follow-up study of a CE marked medical device, controlled, comparative, randomized, multicentre, international single-blind.
The main objective is to evaluate the efficacy and safety of PuraStat in duodenal endoscopic mucosal resection or ampullectomy.
This study will be carried out in France in 3 investigative centers. The duration of patient participation in the study is approximately 37 days depending on the time between the selection and the endoscopic intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single-blind, controlled, comparative, randomized, multicentre, international post-marketing follow-up study of a CE marked medical device.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group with PuraStat® | Experimental | Procedure: duodenal mucosectomy, Procedure: ampullectomyEndoscopic mucosectomy or endoscopic ampullectomy with standard resection technique, per-procedure hemostasis at operator discretion and application of PuraStat® |
| Control Group | Active comparator | Procedure: duodenal mucosectomy, Procedure: ampullectomyEndoscopic mucosectomy or endoscopic ampullectomy with standard resection technique, per-procedural hemostasis at operator discretion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ampullary lesions
- Single ampullary lesion ≥ 10mm
- Resection via hot ampullectomy, injection/Endoscopic mucosal resection of adjacent lateral spreading component Duodenal Lesions
- ≤ 2 lesions
- Lesion ≥15mm
Key exclusion criteria (7 listed)
- Inability to provide informed consent (including people with cognitive impairment);
- Pregnant or breastfeeding women;
- Allergy to PuraStat®;
- "Cold" mucosal endoscopic resection;
- Patient under guardianship or curatorship, or under a regime of deprivation of liberty;
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 |
|---|---|---|
| duodenal mucosectomyStandard resection technique will be performed for duodenal mucosectomy, as well as the usual hemostasis at the discretion of the operator. | Procedure or surgery | Control Group, Experimental Group with PuraStat® |
| ampullectomyStandard resection technique will be performed for ampullectomy, as well as the usual hemostasis at the discretion of the operator. | Procedure or surgery | Control Group, Experimental Group with PuraStat® |
Primary outcome
Bleeding rate requiring further intervention within 30 days
Time frame: 30 days
Rate of clinically significant delayed postoperative bleeding requiring further intervention within 30 days (such as blood transfusion, packed cell transfusion or administration of other blood products, hospitalization or repeat endoscopy)
Results and safety
The study was stopped early (reason given: The sponsor, in consultation with the research team, has decided to terminate the study early. Unfortunately, there have been no new enrollments since October 2025.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing duodenal mucosectomy and ampullectomy in people with Duodenal Bleeding, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 7 inclusion and 7 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: stopped early, as of the sponsor's last update on 27 Oct 2026. 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?
The study was stopped early (reason given: The sponsor, in consultation with the research team, has decided to terminate the study early. Unfortunately, there have been no new enrollments since October 2025.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding rate requiring further intervention within 30 days (time frame: 30 days). 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 27 Oct 2026.