PerClot Compared to Usual Care in Gynaecology Procedures

Study Overview
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Brief Summary
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This study is a post market, multi-centre, randomised study evaluating PerClot compared to usual care. PerClot is a CE marked device and is currently used as a haemostat in gynaecological surgery throughout Europe. The purpose of this study is to collect additional post market data on its use in this indication.

Detailed Description
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This study is a post market, multi-centre, randomised study evaluating PerClot compared to usual care. All subjects in this randomized study will undergo a laparoscopic or open gynecological procedure such as hysterectomy, cystectomy, myomectomy, endometrial excision or ablation. Subjects will be randomized to receive PerClot or usual care. This research will utilize a multi-center, prospective, randomized controlled study. The study will be conducted in2 study sites in Europe. An assumed sample of 90 subjects will be enrolled to evaluate the time to haemostasis. The enrollment of subjects to receive treatment will be based upon specific inclusion and exclusion criteria. Subjects will be randomized on a 1:1 basis to receive either PerClot or usual care. Data collected from both arms will be compared. Usual care will be at the discretion of the surgeon and may include any other haemostat or diathermy/electrocautery.

Official Title
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A Prospective, Multi-Centre, Randomized, Safety and Effectiveness Study of PerClot Compared to Usual Care When Used During Gynaecology Procedures

Conditions
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Endometriosis, Ovarian Cyst, Menorrhagia, Cancer, Uterine Fibroids

Intervention / Treatment
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* Device: PerClot
* Device: Floseal, Surgicel, Surgiflo, Arista
* Procedure: Electrocautery/Diatermy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is ≥ 18 years of age Subject is undergoing gynecological procedure Subject is willing and able to comply with the protocol and follow up period Subject is willing and able to give written informed consent Exclusion Criteria: • Subject with a history of pelvic or abdominal radiotherapy (within 8 weeks) Subject is pregnant or actively breastfeeding Subject has a ruptured ectopic pregnancy Subject has a medical history of abnormal coagulopathy or bleeding Subject has a sensitivity to starch or starch derived materials Subject has active or potential infection at the surgical site Subject is currently enrolled in another study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PerClot<br>PerClot® Polysaccharide Hemostatic System (PerClot) is a medical device composed of absorbable polysaccharide particles (AMPs) and delivery applicators. Investigators will have the option to choose 3g or 5g dependent on the requirements of the patient | Device: PerClot<br>* Haemostatic device for the control of bleeding from capillary, venous or arteriolar vessels by pressure, ligature or other conventional means is either ineffective or impractical.<br>|
| Active Comparator: Usual Care<br>Usual care will consist of any other haemostat the Investigator would normally use in the control of bleeding i.e arista, Floseal, surgical, surgiflo. If the Investigator would not normally use a haemostat to control bleeding then electrocautery or diathermy may be used in this arm | Device: Floseal, Surgicel, Surgiflo, Arista<br>* Haemostatic device for the control of bleeding<br>Procedure: Electrocautery/Diatermy<br>* Procedure for the control of bleeding<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| achievement of haemostasis (yes/no). | visual observation of cessation of bleeding | measured up to 10 minutes after application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of re-intervention for post-operative bleeding | No return to OR for bleeding | within 30 days of initial surgery |