NCT05705557 Efficacy of ABSOLOK™ Clip System-RFP-2021-01 in Open Liver Resection
| NCT ID | NCT05705557 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Bile Leak |
| Study Type | OBSERVATIONAL |
| Enrollment | 180 participants |
| Start Date | 2023-01-30 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 180 participants in total. It began in 2023-01-30 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this prospective observational study is to evaluate the incidence of Post-Operative Bile Leakage (POBL) using the ABSOLOK™ Clip System during liver parenchymal resection by evaluating the intraoperative and short-term postoperative results. In addition, it will attempt to determine the factors that determine the surgeon's peripheral glissonian pedicle closure method and economic outcomes.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years; * Subject has given his informed consent and signed consent; * Patients undergoing open liver resection. Exclusion Criteria: * Surgery made in emergency; * Surgery by laparoscopy; * Need to perform a bilio-digestive anastomosis; * Preoperative jaundice (total bilirubin \> 3 mg/mL).
Contact & Investigator
Felice Giulante, MD
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Frequently Asked Questions
Who can join the NCT05705557 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bile Leak. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05705557 currently recruiting?
Yes, NCT05705557 is actively recruiting participants. Contact the research team at felice.giuliante@policlinicogemelli.it for enrollment information.
Where is the NCT05705557 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT05705557 clinical trial?
NCT05705557 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Felice Giulante, MD at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 180 participants.