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PerClot Compared to Usual Care in Gynaecology Procedures

C

CryoLife

Status

Completed

Conditions

Uterine Fibroids
Ovarian Cyst
Endometriosis
Cancer
Menorrhagia

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT02835391
PCT1501-000-C(01/15)

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

90 participants in 2 patient groups

PerClot
Active Comparator group
Description:
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
Treatment:
Device: PerClot
Usual Care
Active Comparator group
Description:
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
Treatment:
Device: Floseal, Surgicel, Surgiflo, Arista
Procedure: Electrocautery/Diatermy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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