Clinical trial · Interventional
First-in-Human Safety Study Of Laser Tissue Welding For Surtureless Laparoscopic Partial Nephrectomy
Phase-I Feasibility Trial To Study The Safety Of Laser Tissue Welding For Sealing Resected Kidney Surfaces After Laparoscopic Partial Nephrectomy
NCT02061605CI-TRIAL-00057575LTW-KIDNEYwithdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign Renal Tumors | Benign Kidney Neoplasm | ALIAS | 0.90 |
| Malignant Renal Tumors | Malignant Kidney Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laser Tissue Welding Device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Laser Tissue Welding Device
- description
- The laser tissue welding device is intended for use in patients requiring laparoscopic surgery requiring hemostasis and sealing of the resected kidney after partial nephrectomy, and including those patients who are fully heparinized or have hemodilutional coagulation failure. The device's intended use is to seal the kidney surface using a laser to weld human albumin based biomaterials after surgical removal of kidney tumors during a laparoscopic partial nephrectomy.
- interventionNames
- Device: Laser Tissue Welding Device
Primary outcomes (2)
- measure
- Operative Blood Loss
- timeFrame
- Day 1
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. T1a (\< 4 cm). All resectable benign, primary or secondary malignant tumors of one kidney. No bi-lateral disease. 2. Serum creatinine: ≤ 2.5 mg/dL 3. Glomerular filtration rate greater than ≥ 50 ml/min/m2 4. Platelet count ≥ 50,000/mm3 5. Prothrombin time \< 18 seconds 6. Partial thromboplastin time (PTT) ≤ 1.5 times control 7. Serum albumin levels \> 3g/dL (Normal range 3.5 to 5 g/dL) Exclusion Criteria: 1. Age younger than 18 years old 2. Severe uncorrected hypertension 3. Uncorrectable coagulopathies 4. Pregnancy 5. Active urinary tract infection 6. T1b (\>4 cm) lesion and above 7. Systemic or local infection 8. Subject has known allergy or intolerance to iodine or human serum albumin 9. Recent febrile illness that precludes or delays participation pre-operatively 10. Treatment with another investigational drug or other intervention during the study and follow-up period.
References
Publications (0)
Data not yet available
No reference posted for this study.