Phase-I Feasibility Trial To Study The Safety Of Laser Tissue Welding For Sealing Resected Kidney Surfaces After Laparoscopic Partial Nephrectomy (LTW-KIDNEY)

NCT02061605 NA WITHDRAWN

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.

Details

Lead sponsor	Laser Tissue Welding, Inc.
Phase	NA
Status	WITHDRAWN
Start date	2016-06
Completion	2020-12

Conditions

• Benign Renal Tumors
• Malignant Renal Tumors

Interventions

• Laser Tissue Welding Device

Primary outcomes

• Operative Blood Loss — Day 1
  Operative blood loss is defined by: Volume of blood in the suction bottles, volume of blood clots, and weight of surgical towels before and after use. Clinical assessment of the blood loss: Clinical drop in hemoglobin (1 gm. % = 300 ml) without hemo-dilution. Therefore is correlated with blood products transfused to compensate for the blood lost during surgery.
• Postoperative Blood Loss — Up to 30 days
  Clinical assessment of the blood loss: 1. Clinical drop in hemoglobin (1 gm. % = 300 ml) without hemodilution. Therefore is correlated with blood products transfused to compensate for the blood lost post-operatively. 2. Correlated to post-operative JP tube drainage, amount and type.

Countries

United States