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First-in-Human Safety Study Of Laser Tissue Welding For Surtureless Laparoscopic Partial Nephrectomy

NCT02061605 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-04-06

No results posted yet for this study

Summary

The objective of this pilot study will be to obtain a clinical safety and efficacy endpoint profile of laser tissue welding therapy for sealing the resected kidney surface after laparoscopic partial nephrectomy required for removal of resectable benign or malignant renal tumors in 10 patients.

Conditions

  • Benign Renal Tumors
  • Malignant Renal Tumors

Interventions

DEVICE

Laser Tissue Welding Device

Laparoscopic partial nephrectomy will be robotically assisted using the second generation da Vinci® Surgical System. Once the tumor is resected with laparoscopic scissors with a margin of healthy tissue, the solder will be dripped onto the cut surface of the parenchyma. A laparoscopic rigid 5mm spot-size laser hand-piece will be passed through the 10-mm port. The diode laser will be then used to weld a thin layer of solder onto the cut parenchymal surface. The 60 Watt 810-nm diode laser will be set to deliver continuous energy. During soldering, the tip of the laparoscopic laser hand-piece will be maintained 1 to 2 cm from the renal surface to generate a spot size of approximately 5 mm. Each spot will be treated with the laser until the color of the solder changes from green to white. The renal pedicle clamp will be removed to allow renal blood supply to be restored and the surgical site inspected for evidence of bleeding for 10 minutes prior to completing the surgical procedure.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Laser Tissue Welding, Inc.

    lead INDUSTRY

Principal Investigators

  • RICHARD LINK, M.D. · Department of Urology, Baylor College of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02061605 on ClinicalTrials.gov