Open vs Robotic Assisted Partial Nephrectomy

NCT03849820 | Terminated FDA Device

• 1 other identifier: OpeRa-2018
• Study Type: interventional
• Target: 247
• Locations: 1 country
• Sites: 12

Brief Summary

To demonstrate that Robotic-Assisted partial nephrectomy is superior to Open partial nephrectomy in reducing the number of 30 day post-operative complications (Clavien-Dindo Type I-V) for patients with intermediate to high complexity kidney tumors.

Conditions

Renal Cancer

Keywords

Robotic-assisted Surgery; Open Surgery; Partial Nephrectomy; minimal invasive surgery; RAS; MIS

Outcome Measures

Primary Outcomes (1)

• 30 day complications

  Any complication that occurred within 30 days post surgery

  Day of surgery to 30th post operative day

Secondary Outcomes (20)

• Operative time

  Day of surgery

• Ischemia time

  Day of surgery

• Surgical radicality conversions

  Day of surgery

• Intraoperative blood loss

  Day of surgery

• Pain assessment

  Baseline until Day 90

Study Arms (2)

Robotic-assisted partial nephrectomy

ACTIVE COMPARATOR

da Vinci surgical robotic assisted partial nephrectomy

Device: Robotic-assisted partial nephrectomy

Open partial nephrectomy

ACTIVE COMPARATOR

Open partial nephrectomy surgery

Other: Open partial nephrectomy

Interventions

Robotic-assisted partial nephrectomy DEVICE

Application of the da Vinci surgical robot to assist the partial nephrectomy

Also known as: da Vinci, RAS, dVPN

Robotic-assisted partial nephrectomy

Open partial nephrectomy OTHER

Open surgery to conduct the partial nephrectomy

Also known as: Open surgery

Open partial nephrectomy

Eligibility Criteria

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

You may qualify if:

• Age 18 years or older
• Patient with a renal tumor that is a candidate for OPEN surgery and robotic assisted surgery (RAS) partial nephrectomy (PN)
• R.E.N.A.L. score ≥ 7
• eGFR ≥ 50 ml/min/1.73 m²
• Anticoagulation is accepted according to the surgeon's practice

You may not qualify if:

• Solitary kidney or functionally solitary kidney
• Prior surgery at the affected kidney excluding endoscopic kidney stone surgery
• Bilateral tumors
• Multiple renal tumors requiring excision
• Renal vein tumor thrombus
• Likely insufficient volume of remaining parenchyma after partial nephrectomy to maintain viable kidney remnant
• Metastatic disease with life expectancy of less than 1 year
• Pregnancy or suspected pregnancy
• Planned concomitant procedure
• Subject who is unable or unwilling to comply with the protocol requirements
• Subject considered to be from a vulnerable population according to IS0 14155:2011

Sponsors & Collaborators

• Intuitive Surgical: lead

Study Sites (12)

Dept. of Urology, University Hospital Tübingen

Tübingen, Germany, 72076, Germany

Location

Department of Urology, University Hospital Düsseldorf

Düsseldorf, 40225, Germany

Location

Department of Urology, Alfried Krupp Krankenhaus Rüttenscheid

Essen, 45131, Germany

Location

Department of Urology, University Hospital Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Universitätsklinik und Poliklinik für Urologie

Halle, 06120, Germany

Location

Universitätsklinikum Heidelberg, Urologische Klinik

Heidelberg, 69120, Germany

Location

Klinik für Urologie, Marien Hospital Herne

Herne, 44625, Germany

Location

Department of Urology - Universitätsklinikum des Saarlandes

Homburg, 66421, Germany

Location

Department of Urology, University Hospital Jena

Jena, 07747, Germany

Location

Klinik für Urologie, Marien-Hospital Marl

Marl, 45768, Germany

Location

Department of Urology, Klinikum rechts der Isar der Technischen Universität

Munich, 81675, Germany

Location

Helios Universitätsklinkum Wuppertal - Department of Urology

Wuppertal, 42283, Germany

Location

Related Publications (1)

• Grimm MO, Bedke J, Nyarangi-Dix J, Khoder W, Foller S, Sommerfeld HJ, Giessing M, Heck M, Meissner W, Slee A, Leucht K, von Rundstedt F, Theil G, Buse S, Siemer S, Albers P, Gratzke C, Hohenfellner M, Stenzl A. Open versus robotic-assisted partial nephrectomy in patients with intermediate/high-complexity kidney tumours: final results of the randomised, controlled, open-label, multicentre trial OpeRa. Ann Oncol. 2025 Aug;36(8):988-998. doi: 10.1016/j.annonc.2025.04.005. Epub 2025 Apr 16.

  PMID: 40250528 BACKGROUND

MeSH Terms

Conditions

Kidney Neoplasms

Interventions

Conversion to Open Surgery

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

Intervention Hierarchy (Ancestors)

Endoscopy; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Marc O Grimm, MD, Prof

  Department of Urology, University Hospital Jena

  PRINCIPAL INVESTIGATOR

• Arnulf Stenzl, MD, Prof

  Dept. of Urology, University Hospital Tübingen, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2019
• First Posted: February 21, 2019
• Study Start: March 12, 2019
• Primary Completion: December 15, 2021
• Study Completion: October 25, 2022
• Last Updated: June 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (12)