Laser Tissue Welding - Distal Pancreatectomy Sealing Study

Summary

The laser tissue welding device is intended for use in patients requiring sealing of the pancreas after partial pancreatectomy, and including those patients who are fully heparinized or have hemodilutional coagulation failure.

The hypothesis is that the laser tissue welding device is safe and effective in sealing the pancreas, thereby decreasing the blood loss (operative and post-operative), and pancreatic juice leakage for patients when the Laser Tissue Welding device is used after pancreatic resection.

Conditions

• Pancreatic Tumor, Benign
• Pancreatic Neoplasms
• Pancreatic Adenocarcinoma
• Pancreatic Pseudocyst
• Pancreatic Neuroendocrine Tumor
• Pancreas; Insulinoma
• Pancreatic Cyst
• Pancreatic Teratoma
• Pancreatic Polypeptide Tumor
• Pancreatic Vipoma
• Pancreatic Cystadenoma
• Pancreas Injury
• Pancreatic Gastrinoma
• Pancreatic Glucagonoma

Interventions

DEVICE

Distal Pancreatectomy Sealing Using LTW

The device's intended use is to seal the pancreatic surface using a laser to weld human albumin based biomaterials after surgical removal of pancreatic tumors during a partial pancreatectomy.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• CHI St. Luke's Health, Texas

  collaborator OTHER

• Laser Tissue Welding, Inc.

  lead INDUSTRY

Principal Investigators

• OMAR BARAKAT, M.D · Baylor CHI St. Luke's Medical Center, Houston, Texas

• STEPHEN HAROLD, M.D.; MPH; CCRC · Baylor CHI St. Luke's Medical Center, Houston, Texas

Study Design

Allocation

NA

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-01-01

Primary Completion

2021-12-31

Completion

2021-12-31

FDA Device

Yes

Countries

• United States

Study Locations