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

NCT02061605 | Withdrawn DMC

• 2 other identifiers: LTW-LPN-01R44DK094619-02
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Laparoscopic partial nephrectomy; Surgical hemostasis; Laser tissue welding; Tissue sealant

Outcome Measures

Primary Outcomes (2)

• Operative Blood Loss

  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.

  Day 1

• Postoperative Blood Loss

  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.

  Up to 30 days

Secondary Outcomes (4)

• Secondary hemorrhage or hematoma (safety issue no. 1)

  Up to 12 months

• Post-operative urinary leakage/ urinoma (safety issue no. 2)

  Up to 12 months

• Secondary infection, intra-abdominal abscess formation and septicemia (safety issue no. 3)

  Up to 12 months

• Urinary stone formation (safety issue no. 4)

  Up to 12 months

Other Outcomes (5)

• Total operating time (minutes) (Duration Metric -1)

  Day 1

• Nephrectomy clamp time (minutes) (Duration Metric-2)

  Day 1

• Laser tissue welding time (sec/cm2) (Duration Metric-3)

  Day 1

Study Arms (1)

Laser Tissue Welding Device

EXPERIMENTAL

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.

Device: Laser Tissue Welding Device

Interventions

Laser Tissue Welding Device 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.

Laser Tissue Welding Device

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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
• Recent febrile illness that precludes or delays participation pre-operatively
• Treatment with another investigational drug or other intervention during the study and follow-up period.

Sponsors & Collaborators

• Laser Tissue Welding, Inc.: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

St. Luke's Episcopal Hospital

Houston, Texas, 77030, United States

Location

Related Links

• Laser Tissue Welding, Inc

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• RICHARD LINK, M.D.

  Department of Urology, Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 6, 2014
• First Posted: February 13, 2014
• Study Start: June 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 6, 2022

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)