NCT02835391

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
9 months until next milestone

First Posted

Study publicly available on registry

July 18, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

September 1, 2017

Status Verified

July 1, 2016

Enrollment Period

1.7 years

First QC Date

July 31, 2015

Last Update Submit

August 31, 2017

Conditions

EndometriosisOvarian CystMenorrhagiaCancerUterine Fibroids

Outcome Measures

Primary Outcomes (1)

  • achievement of haemostasis (yes/no).

    visual observation of cessation of bleeding

    measured up to 10 minutes after application

Secondary Outcomes (1)

  • Absence of re-intervention for post-operative bleeding

    within 30 days of initial surgery

Other Outcomes (2)

  • Absence of proven infection

    within 30 days of initial surgery

  • Absence of bleeding related adverse events

    within 30 days of initial surgery

Study Arms (2)

PerClot

ACTIVE COMPARATOR

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

Usual Care

ACTIVE COMPARATOR

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, AristaProcedure: Electrocautery/Diatermy

Interventions

PerClotDEVICE

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.

PerClot
Floseal, Surgicel, Surgiflo, AristaDEVICE

Haemostatic device for the control of bleeding

Usual Care
Electrocautery/DiatermyPROCEDURE

Procedure for the control of bleeding

Usual Care

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bellvitge Hospital

Barcelona, 08907, Spain

Location

Related Publications (1)

  • Ponce J, Garcia-Tejedor A, Barahona M, Cappuccio S, Costantini B, Fedele C, Marti-Cardona L, Scambia G. Effectiveness and safety of an absorbable modified polymer starch powder hemostat versus usual care in gynecology procedures: A prospective, multi-center, and randomized study. PLoS One. 2025 Sep 11;20(9):e0331376. doi: 10.1371/journal.pone.0331376. eCollection 2025.

    PMID: 40934160DERIVED

MeSH Terms

Conditions

EndometriosisOvarian CystsMenorrhagiaNeoplasmsLeiomyoma

Interventions

Electrocoagulation

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesCystsOvarian DiseasesAdnexal DiseasesGonadal DisordersEndocrine System DiseasesUterine HemorrhageUterine DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsMenstruation DisturbancesNeoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

CauteryTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2015

First Posted

July 18, 2016

Study Start

November 1, 2015

Primary Completion

July 1, 2017

Study Completion

August 1, 2017

Last Updated

September 1, 2017

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)