WithdrawnNot Applicable

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

United States0Started 2016-06

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. T1a (\< 4 cm). All resectable benign, primary or secondary malignant tumors of one kidney. No bi-lateral disease.
✓. Serum creatinine: ≤ 2.5 mg/dL
✓. Glomerular filtration rate greater than ≥ 50 ml/min/m2
✓. Platelet count ≥ 50,000/mm3
✓. Prothrombin time \< 18 seconds
✓. Partial thromboplastin time (PTT) ≤ 1.5 times control
✓. Serum albumin levels \> 3g/dL (Normal range 3.5 to 5 g/dL)

Exclusion criteria

✕. Age younger than 18 years old
✕. Severe uncorrected hypertension
✕. Uncorrectable coagulopathies
✕. Pregnancy
✕. Active urinary tract infection
✕. T1b (\>4 cm) lesion and above
✕. Systemic or local infection
✕. Subject has known allergy or intolerance to iodine or human serum albumin

What they're measuring

Operative Blood Loss

Timeframe: Day 1

Postoperative Blood Loss

Timeframe: Up to 30 days

Trial details

NCT IDNCT02061605

SponsorLaser Tissue Welding, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-12

View on ClinicalTrials.gov More Benign Renal Tumors trials