PerClot Compared to Usual Care in Gynaecology Procedures

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02835391
• Other study ID #: PCT1501-000-C(01/15)
• Status: Completed
• Phase: N/A
• First received: July 31, 2015
• Last updated: August 31, 2017
• Start date: November 2015
• Est. completion date: August 2017

Study information

• Verified date: July 2016
• Source: CryoLife Europa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Endometriosis
• Leiomyoma
• Menorrhagia
• Ovarian Cyst
• Ovarian Cysts
• Uterine Fibroids

Intervention

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.
• Floseal, Surgicel, Surgiflo, Arista
Haemostatic device for the control of bleeding

Procedure:
• Electrocautery/Diatermy
Procedure for the control of bleeding

Locations

Country	Name	City	State
Spain	Bellvitge Hospital	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
CryoLife Europa

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Absence of proven infection	No positive culture of blood results which indicate infection	within 30 days of initial surgery
Other	Absence of bleeding related adverse events	No adverse events which are specifically caused by bleeding	within 30 days of initial surgery
Primary	achievement of haemostasis (yes/no).	visual observation of cessation of bleeding	measured up to 10 minutes after application
Secondary	Absence of re-intervention for post-operative bleeding	No return to OR for bleeding	within 30 days of initial surgery