A Novel Haemostatic Agent for Robotic Partial Nephrectomy

NCT07284953 | Withdrawn DMC

• 1 other identifier: 2024SUR137
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Kidney Cancer; Renal Cell Carcinoma

Keywords

Robotic Partial Nephrectomy; PuraBond

Outcome Measures

Primary Outcomes (1)

• Intraoperative efficacy rate in stopping remaining mild and moderate bleeding after declamping within 2 minutes

  During robotic partial nephrectomy procedure

Secondary Outcomes (5)

• Time to Haemostasis after PuraBond application

  During robotic partial nephrectomy procedure

• The amount of PuraBond needed to achieve haemostasis

  During robotic partial nephrectomy procedure

• Ease of use of PuraBond (difficult or easy)

  During robotic partial nephrectomy procedure

• Rate of revision for bleeding

  During robotic partial nephrectomy procedure

• Radiomics score of tissue healing at 6 months post op CT scan

  6 months

Study Arms (1)

PuraBond

EXPERIMENTAL

Collect medical information on patients who were treated with PuraBond during robotic partial nephrectomy, according to each participating institution's procedures and standards of care. Evaluate the feasibility, safety and efficacy of PuraBond in achieving haemostasis and post operative healing at the resection site compared to standard of care agent for robotic partial nephrectomy procedures

Device: PuraBond

Interventions

PuraBond DEVICE

Consecutive patients undergoing robotic partial nephrectomy procedure (primary resection) and treated with PuraBond

PuraBond

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant or Lactating women
• Unable to give informed consent
• Patient undergoing redo surgery
• Fibrin glue and/or topical haemostatic agent used before or concomitantly to the use of PuraBond
• Known allergy or hypersensitivity to any component of the investigational treatment PuraBond
• Known coagulopathy
• Patient has clinical evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments during the study duration
• Patients currently participating in, or planning to enroll in another clinical study that may impact participation or outcomes of this clinical study.

Sponsors & Collaborators

• The Royal Wolverhampton Hospitals NHS Trust: lead

Study Sites (1)

The Royal Wolverhampton NHS Trust

Wolverhampton, WV10 0QP, United Kingdom

Location

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Patients will be randomised to PuraBond or standard care of Floseal to stop the bleeding after renorrhaphy suture when undergoing a robotic partial nephrectomy procedure (primary resection).

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 16, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)