A Evaluation of the Utilisation, Effectiveness and Safety of Purastat® in the Management of Gastrointestinal Bleeding (POPS)
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| ClinicalTrials.gov Identifier: NCT03983707 |
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Recruitment Status :
Recruiting
First Posted : June 12, 2019
Last Update Posted : June 12, 2019
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Problem statement
GI bleeding can arise from peptic ulcers, malignancy, angiodysplasia or during endoscopic resection procedures such as endoscopic mucosal resection and endoscopic submucosal dissection. This is conventionally treated using heat therapy or clips. These methods carry a risk of thermal injury or perforation. Purastat® is a novel synthetic haemostatic agent licensed as a CE marked device for use in GI bleeding. It also has the potential to enhance endoscopic mucosal wound healing and may play a role in preventing delayed bleeding. However, clinical data on its effectiveness in the GI tract is limited. Prospective data collection on the range of indications for Purastat® use and outcome data related to clinical effectiveness, safety and feasibility is required to inform clinicians about the best use for this agent.
Research question / hypothesis
To establish a prospective registry study to collect outcome data related to the use of Purastat® for the clinical management of GI bleeding or prevention of bleeding
Study Design
Prospective multicentre cohort study
Study Participants
Adults with GI bleeding or a high risk of bleeding during endoscopic procedures where Purastat® has been used
Follow-up duration
All patients will be followed up as per standard clinical care where applicable
Planned Study Period
2 years
Primary Objective
To assess the effectiveness of Purastat® as a haemostatic agent when used in the treatment of GI bleeding
Secondary Objectives
To assess the incidence of delayed bleeding after use of Purastat®, defined as procedure related bleeding up to 28 days following endoscopic resection To evaluate the rate of rebleeding following primary application of Purastat® for haemostasis To assess the technical feasibility and ease of use of Purastat® when used in the treatment or prevention of GI bleeding To monitor any unexpected reactions that may be attributed to the use of Purastat® To describe utilisation patterns in different clinical centres (indication, patient characteristics etc) and to observe trends in utilisation over time
| Condition or disease | Intervention/treatment |
|---|---|
| Gastrointestinal Bleeding | Device: Purastat® |
Problem statement
GI bleeding can arise from peptic ulcers, malignancy, angiodysplasia or during endoscopic resection procedures such as endoscopic mucosal resection and endoscopic submucosal dissection. This is conventionally treated using heat therapy or clips. These methods carry a risk of thermal injury or perforation. Purastat® is a novel synthetic haemostatic agent licensed as a CE marked device for use in GI bleeding. It also has the potential to enhance endoscopic mucosal wound healing and may play a role in preventing delayed bleeding. However, clinical data on its effectiveness in the GI tract is limited. Prospective data collection on the range of indications for Purastat® use and outcome data related to clinical effectiveness, safety and feasibility is required to inform clinicians about the best use for this agent.
Research question / hypothesis
To establish a prospective registry study to collect outcome data related to the use of Purastat® for the clinical management of GI bleeding or prevention of bleeding
Study Design
Prospective multicentre cohort study
Study Participants
Adults with GI bleeding or a high risk of bleeding during endoscopic procedures where Purastat® has been used
Follow-up duration
All patients will be followed up as per standard clinical care where applicable
Planned Study Period
2 years
Primary Objective
To assess the effectiveness of Purastat® as a haemostatic agent when used in the treatment of GI bleeding
Secondary Objectives
To assess the incidence of delayed bleeding after use of Purastat®, defined as procedure related bleeding up to 28 days following endoscopic resection To evaluate the rate of rebleeding following primary application of Purastat® for haemostasis To assess the technical feasibility and ease of use of Purastat® when used in the treatment or prevention of GI bleeding To monitor any unexpected reactions that may be attributed to the use of Purastat® To describe utilisation patterns in different clinical centres (indication, patient characteristics etc) and to observe trends in utilisation over time
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 200 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 28 Days |
| Official Title: | A Multicentre Prospective Observational Study to Evaluate the Utilisation, Effectiveness and Safety of Purastat® in the Management of Gastrointestinal Bleeding |
| Actual Study Start Date : | January 23, 2019 |
| Estimated Primary Completion Date : | January 23, 2021 |
| Estimated Study Completion Date : | February 23, 2021 |
- Device: Purastat®
Use of Purastat®
- Effectiveness of Purastat® in controlling bleeding [ Time Frame: Day 1 (intraprocedural bleeding) ]Number (and proportion) of bleeds successfully controlled by application of Purastat®
- Effectiveness of Purastat® in controlling bleeding [ Time Frame: Day 28 (delayed bleeding) ]Number (and proportion) of bleeds successfully controlled by application of Purastat®
- Effectiveness of Purastat® in preventing delayed bleeding [ Time Frame: Day 28 ]Delayed bleeding rate
- Technical feasibility of use of Purastat® [ Time Frame: Day 1 (periprocedural) ]Any difficulty in Purastat application (yes/no)
- Unexpected reactions that may be attributed to the use of Purastat® [ Time Frame: Day 28 ]Occurrence of Suspected Unexpected Serious Adverse Reactions (SUSAR) related to Purastat®
- Patterns of Purastat® usage [ Time Frame: 24 months ]Purastat® utilisation (including indications)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Active GI bleeding or high risk for active GI bleeding
Exclusion Criteria:
- Variceal or arterial bleeding
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03983707
| Contact: Pradeep Bhandari | 023 9228 6000 ext 5852 | pradeep.bhandari@porthosp.nhs.uk | |
| Contact: Laura Marshall | 023 9228 6000 ext 5455 | Laura.Marshall2@porthosp.nhs.uk |
| United Kingdom | |
| Queen Alexandra Hospital | Recruiting |
| Portsmouth, Hampshire, United Kingdom, PO6 3LY | |
| Contact: Alice Mortlock 023 9228 6000 ext 4042 alice.mortlock@porthosp.nhs.uk | |
| Contact: Laura Marshall 02392 286000 ext 5455 Laura.Marshall2@porthosp.nhs.uk | |
| Principal Investigator: | Pradeep Bhandari | Portsmouth Hospitals NHS Trust |
| Responsible Party: | Portsmouth Hospitals NHS Trust |
| ClinicalTrials.gov Identifier: | NCT03983707 |
| Other Study ID Numbers: |
PHT/2018/39 |
| First Posted: | June 12, 2019 Key Record Dates |
| Last Update Posted: | June 12, 2019 |
| Last Verified: | June 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Purastat |
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Gastrointestinal Hemorrhage Hemorrhage Pathologic Processes Gastrointestinal Diseases Digestive System Diseases |