A Novel Haemostatic Agent for Robotic Partial Nephrectomy

Trial details

Who runs it

The Royal Wolverhampton Hospitals NHS Trust

Trial code

NCT07284953

Record updated

2026. március 13.

Original description

Kidney cancer is one of only a few cancers with an increasing incidence over the past two decades. Renal cell carcinoma (RCC) accounts for over 85% of all kidney tumours, which makes up 2-3% of all adult malignancies. Approximately, 70% of RCCs are incidentally discovered on axial imaging of the abdomen with >50% of RCCs being low-stage (T1-T2 N0M0). Despite advancements in drug discovery for advanced RCC, mortality rates have not changed over the past two decades, however for patients with the low-stage disease, surgical extirpation offers excellent 5-year survival rates of 95%.Read full original descriptionShow less

A Pilot, Single Arm Post-Market Clinical Study to Demonstrate the Feasibility, Safety and Efficacy of PuraBond™ Absorbable Haemostatic Material for the Management of Bleeding and Tissue Healing in Robotic Partial Nephrectomy

Kidney cancer is one of only a few cancers with an increasing incidence over the past two decades. Renal cell carcinoma (RCC) accounts for over 85% of all kidney tumours, which makes up 2-3% of all adult malignancies. Approximately, 70% of RCCs are incidentally discovered on axial imaging of the abdomen with >50% of RCCs being low-stage (T1-T2 N0M0). Despite advancements in drug discovery for advanced RCC, mortality rates have not changed over the past two decades, however for patients with the low-stage disease, surgical extirpation offers excellent 5-year survival rates of 95%.

Nephron-sparing surgery (NSS) provides effective curative therapy for patients with localized renal cell carcinoma with the benefit of kidney preservation and excellent cancer-specific survival. However, the most frequent complications during NSS, after tumour resection are bleeding, urinary fistula formation, and ischemic renal damage. More precisely, the urological complication was defined as significant haemorrhage >500 mL necessitating intervention or transfusion, urine leakage (drainage of greater than 50 mL daily for more than one week with fluid biochemistry compatible with urine) and acute renal failure (resulting in any dialysis, ureteral obstruction or kidney loss).

In the field of partial nephrectomy procedures, it is therefore crucial achieving adequate haemostasis intraoperatively during post tumour excision while the artery is clamped and after being unclamped.

Inclusion: Male or female patients, aged 18 years or above; Patient has a clinical indication for laparoscopic partial nephrectomy procedure; Participant is willing and able to give informed consent for participation in the study; Intraoperative criteria: Subject requiring the use of PuraBond for persisting mild and moderate bleeding(s) when haemostasis by ligation or standard means are insufficient or impractical.

Exclusion: Patient undergoing redo surgery; Known allergy or hypersensitivity to any component of the investigational treatment PuraBond; Patient has clinical evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments during the study duration; Pregnant or Lactating women; Unable to give informed consent; Fibrin glue and/or topical haemostatic agent used before or concomitantly to the use of PuraBond; Known coagulopathy; Clinical indication not satisfying inclusion criteria; Patients currently participating in, or planning to enroll in another clinical study that may impact participation or outcomes of this clinical study.

ClinicalTrials.gov NCT07284953