PerClot Compared to Usual Care in Gynaecology Procedures

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)

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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