EndometriosisNCT02835391
PerClot Compared to Usual Care in Gynaecology Procedures
A study testing PerClot, Floseal, Surgicel, Surgiflo, Arista and Electrocautery/Diatermy in people with Endometriosis and Ovarian Cyst, run by CryoLife Europa at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis, Ovarian Cyst, Menorrhagia
- What is being tested?
- PerClot, Floseal, Surgicel, Surgiflo, Arista and Electrocautery/Diatermy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2015to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- • 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Multi-Centre, Randomized, Safety and Effectiveness Study of PerClot Compared to Usual Care When Used During Gynaecology Procedures
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.
Read the 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.
- Conditions
- Endometriosis, Ovarian Cyst, Menorrhagia, Cancer, Uterine Fibroids
- Being tested
- PerClot, Floseal, Surgicel, Surgiflo, Arista, Electrocautery/Diatermy
- Medical subject headings
- Endometriosis, Ovarian Cysts, Menorrhagia, Neoplasms, Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Floseal, Surgicel, Surgiflo, AristaDevice
Haemostatic device for the control of bleeding
Electrocautery/DiatermyProcedure or surgery
Procedure for the control of bleeding
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Floseal, Surgicel, Surgiflo, Arista; Procedure: Electrocautery/Diatermy |
What is being measured
The primary outcome is the main question the study is designed to answer.
achievement of haemostasis (yes/no).
visual observation of cessation of bleeding
Measured: measured up to 10 minutes after application
Secondary outcomes (1)
Absence of re-intervention for post-operative bleeding
No return to OR for bleeding
Measured: within 30 days of initial surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2016 (estimated)
- Study startNov 2015
- Primary completionJul 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- CryoLife Europa
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02835391
- Sponsor's protocol ID
- PCT1501-000-C(01/15)
- Status last verified
- Jul 2016
- First submitted
- 31 Jul 2015
- Last updated
- 1 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 40934160
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Centre, Randomized, Safety and Effectiveness Study of PerClot Compared to Usual Care When Used During Gynaecology Procedures
- ClinicalTrials.gov ID
- NCT02835391
- Acronym / sponsor ID
- PCT1501-000-C(01/15)
- Conditions
- Endometriosis, Ovarian Cyst, Menorrhagia, Cancer, Uterine Fibroids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- CryoLife EuropaIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Jul 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 18 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PerClot | Active comparator | Device: PerClotPerClot® 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 |
| Usual Care | Active comparator | Device: Floseal, Surgicel, Surgiflo, Arista, Procedure: Electrocautery/DiatermyUsual 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- • Subject with a history of pelvic or abdominal radiotherapy (within 8 weeks)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PerClotHaemostatic device for the control of bleeding from capillary, venous or arteriolar vessels by pressure, ligature or other conventional means is either ineffective or impractical. | Device | PerClot |
| Floseal, Surgicel, Surgiflo, AristaHaemostatic device for the control of bleeding | Device | Usual Care |
| Electrocautery/DiatermyProcedure for the control of bleeding | Procedure or surgery | Usual Care |
Primary outcome
achievement of haemostasis (yes/no).
Time frame: measured up to 10 minutes after application
visual observation of cessation of bleeding
1 secondary outcome
Absence of re-intervention for post-operative bleeding
Time frame: within 30 days of initial surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2017.
- Derived from this study: PubMed 40934160Ponce 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PerClot, Floseal, Surgicel, Surgiflo, Arista and Electrocautery/Diatermy in people with Endometriosis and Ovarian Cyst, run by CryoLife Europa at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
achievement of haemostasis (yes/no). (time frame: measured up to 10 minutes after application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02835391, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2017.