CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 11 enrolled
Drug / intervention
Distal Pancreatectomy Sealing Using LTWdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03147768
NCT03147768Phase 1Completed
CompareCT.gov

Phase I Feasibility Trial To Study The Safety Of Sealing Resected Pancreatic Surfaces After Partial Distal Pancreatectomy Using Laser Tissue Welding

Laser Tissue Welding, Inc.·interventional·Posted May 10, 2017·Updated Apr 6, 2022

In Brief

A Phase 1 clinical trial evaluating Distal Pancreatectomy Sealing Using LTW for Pancreatic Tumor, Benign and 13 related conditions. Completed, enrolled 11 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPancreatic 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
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI), CHI St. Luke's Health, Texas

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedMay 10, 2017
Enrollment StartJan 1, 2018
Primary CompletionDec 31, 2021
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 9.1 years ago

Interventions

Distal Pancreatectomy Sealing Using LTWdevice

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.