Laser Tissue Welding - Distal Pancreatectomy Sealing Study
Completed · Phase 1
Conditions studied: 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
In brief
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.
Key facts
- Study ID
- NCT03147768
- Run by
- Laser Tissue Welding, Inc.
- People needed
- 11
- Starts
- 2018-01-01
- Expected to finish
- 2021-12-31
- Last updated by the study team
- 2022-04-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Eligible participants will be 18 years and older of both genders.
- T1a (≤ 4 cm, as measured by the maximal dimension by CT or MRI). Final determination of disease stage is made during the operation by the investigator. All resectable cystic, benign, primary or secondary malignant tumors.
- Serum creatinine: ≤ 2.5 mg/dL
- Glomerular filtration rate greater than ≥ 50 ml/min/m2
- Platelet count ≥ 50,000/mm3
- Prothrombin time < 18 seconds
- PTT not >1.5 times control (except for therapeutically; anticoagulated nonrelated medical conditions [e.g., atrial fibrillation]);
- 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 (> 180 systolic and >110 diastolic)
- Uncorrectable coagulopathies (on Plavix, Aspirin or Lovanox)
- Pregnancy
- Females who are breast feeding who do not switch the infant to formula prior to surgery
- 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 preoperatively.
- Treatment with another investigational drug or other intervention during the study and follow-up period.
- Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
Where it is running
- Baylor CHI St. Luke's Medical Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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