Clinical trial NCT02835391: PerClot Compared to Usual Care in Gynaecology Procedures
Official title: A Prospective, Multi-Centre, Randomized, Safety and Effectiveness Study of PerClot Compared to Usual Care When Used During Gynaecology Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometriosis
Ovarian Cyst
Menorrhagia
Cancer
Uterine Fibroids
Lead sponsor: CryoLife Europa
Sponsor class: INDUSTRY
First posted: 2016-07-18
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: achievement of haemostasis (yes/no).
timeFrame: measured up to 10 minutes after application
Secondary outcomes:
measure: Absence of re-intervention for post-operative bleeding
timeFrame: within 30 days of initial surgery
Other outcomes:
measure: Absence of proven infection
timeFrame: within 30 days of initial surgery
measure: Absence of bleeding related adverse events
timeFrame: within 30 days of initial surgery
Locations:
city: Barcelona
country: Spain
facility: Bellvitge Hospital
Study officials:
References: