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NCT03323359
Efficacy and Tolerability of Hemopatch After Hepatic Resection
NA trial testing Hemopatch in Hepatectomy in 98 participants. Status unknown.
17 November 2018
Quick facts
| Lead sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 98 |
| Start date | 17 March 2017 |
| Primary completion | 17 November 2018 |
| Estimated completion | 17 March 2019 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Hemopatch
- Common Surgical Techniques
Conditions studied
- Hepatectomy — all drugs for Hepatectomy →
- Cancer, Metastatic — all drugs for Cancer, Metastatic →
- Hemostasis — all drugs for Hemostasis →
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Who can join
Adults 18 to 75, any sex, with Hepatectomy or Cancer, Metastatic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
* Previous in vitro and in vivo studies detected the Hemopatch Sealing Hemostat® to be a new versatile, self-adhering hemostatic sealing pad consisting of a polyethylene glycol-coated collagen. * Initial study assessed that Hemopatch Sealing Hemostat® can be applied to seal almost any bleeding surface encountered during a range of procedures. The Authors shown that the device is eminently capable in both via laparotomy and laparoscopic approaches, and in patients with impaired coagulation or highly variable anatomies. They support the ease-of-use, application, and immediate hemostatic effect of the patch across a broad range of surgical settings and clinical applications, including solid organ, gastrointestinal, biliopancreatic, endocrine, cardiovascular, and urologic surgeries. * In a recent published case report the authors reported the feasibility in using Hemopatch Sealing Hemostat® for the management of a myocardial wound, performing the procedure on cardiopulmonary bypass, which meant the patient had to be heparinized. Despite these major risk factors for bleeding Hemopatch Sealing Hemostat® managed to contain bleeding and seal the wound without needing any suture. These initial results lead up to future randomized clinical trials with more extensive follow-up to assess which is the real contribution of Hemopatch Sealing Hemostat to reduce postoperative bleeding complications in cases where mechanical or energy-driven hemostasis is not possible or insufficient.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03323359
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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Related trials
Other trials of Hemopatch
Trials testing the same drug.
- NCT04185480 — Evaluating Hemopatch in Reducing Seroma Related Complications Following Axillary Lymph Node Dissection: a Pilot Study · NA · completed
- NCT04185922 — Hemopatch to Prevent Lymphatic Leak After Robotic Prostatectomy and Pelvic Lymph Node Dissection · NA · completed
- NCT03993067 — Hemopatch as a Tool to Prevent Biliary Fistula in Liver Surgery. · NA · completed
- NCT03410914 — Intra-operative Application of HEMOPATCH to the Pancreatic Stump to Prevent Post-operative Pancreatic Fistula Following · Phase 2 · completed
- NCT03450265 — Hemopatch Compared to TachoSil in Postoperative Air Leak Duration After Pulmonary Resection · NA · completed
Other recruiting trials for Hepatectomy
Currently open trials in the same condition.
- NCT07507643 — A Study of Methylprednisolone in People Having Liver Surgery · Phase 3 · recruiting
- NCT07062380 — AI-Based Prediction of HCC Recurrence Patterns After Resection (APAR) · recruiting
- NCT06950827 — Textbook Outcomes of Right Hemihepatectomy in Patients With Hepatocellular Carcinoma · recruiting
- NCT07385521 — The Use of Artificial Intelligence for the Prediction of Recurrence After Resection of Colorectal Liver Metastases · recruiting
- NCT06237751 — Preoperative Sildenafil Administration for Hepatectomy · NA · recruiting
Other Fondazione Policlinico Universitario Agostino Gemelli IRCCS trials
Trials by the same sponsor.
- NCT07514572 — Impact of Estimated Weight and Height on Nutritional Assessment in Elderly · NA · not yet recruiting
- NCT07504679 — Adipose Visceral and Epicardial Risk Evaluation · NA · not yet recruiting
- NCT07520643 — MISTIC Study: Atherosclerosis, Neurocognition & Cardiovascular Signaling · not yet recruiting
- NCT07479238 — Breath Test-Based Assessment of SIBO in Chronic Pancreatitis and Partial Pancreatectomy · not yet recruiting
- NCT07494227 — Development of the SC-IBD Self-Care Measurement Scale · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03323359 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Last refreshed: 8 November 2017
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