Clinical trial · Interventional
PerClot Compared to Usual Care in Gynaecology Procedures
A Prospective, Multi-Centre, Randomized, Safety and Effectiveness Study of PerClot Compared to Usual Care When Used During Gynaecology Procedures
NCT02835391CI-TRIAL-00029397completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Endometriosis | — | UNRESOLVED | — |
| Menorrhagia | — | UNRESOLVED | — |
| Ovarian Cyst | — | UNRESOLVED | — |
| Uterine Fibroids | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Electrocautery/Diatermy | Procedure | — | UNRESOLVED |
| Floseal, Surgicel, Surgiflo, Arista | Device | — | UNRESOLVED |
| PerClot | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- PerClot
- 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
- interventionNames
- Device: PerClot
- type
- ACTIVE_COMPARATOR
- label
- Usual Care
- 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
- interventionNames
- Device: Floseal, Surgicel, Surgiflo, Arista
- Procedure: Electrocautery/Diatermy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDPonce 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 40934160