PerClot Compared to Usual Care in Gynaecology Procedures

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

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.

Study Overview

• Status: Completed
• Conditions: Cancer; Endometriosis; Uterine Fibroids; Menorrhagia; Ovarian Cyst
• Intervention / Treatment: Device: PerClot; Device: Floseal, Surgicel, Surgiflo, Arista; Procedure: Electrocautery/Diatermy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08907
    • Bellvitge Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PerClot; 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; 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.
Active Comparator: Usual Care; 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; Haemostatic device for the control of bleeding; Procedure: Electrocautery/Diatermy; Procedure for the control of bleeding

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absence of proven infection	No positive culture of blood results which indicate infection	within 30 days of initial surgery
Absence of bleeding related adverse events	No adverse events which are specifically caused by bleeding	within 30 days of initial surgery

Collaborators and Investigators

• Sponsor: CryoLife Europa

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: July 31, 2015
• First Submitted That Met QC Criteria: July 13, 2016
• First Posted (Estimate): July 18, 2016

Study Record Updates

• Last Update Posted (Actual): September 1, 2017
• Last Update Submitted That Met QC Criteria: August 31, 2017
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Uterine Diseases; Endocrine System Diseases; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Hemorrhage; Menstruation Disturbances; Neoplasms, Muscle Tissue; Uterine Hemorrhage; Endometriosis; Leiomyoma; Menorrhagia; Ovarian Cysts; Hemostatics; Coagulants; Surgiflo
• Other Study ID Numbers: PCT1501-000-C(01/15)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No