Sponsor study identifier
Secondary identifiers
NIH
interventional
11
1 country
1
Study Start
January 1, 2018
Actual (reported)Primary Completion
December 31, 2021
Actual (reported)Study Completion
December 31, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 8, 2017
Actual (reported)May 10, 2017
Actual (reported)January 1, 2018
Actual (reported)December 31, 2021
Actual (reported)December 31, 2021
Actual (reported)PRIMARY EFFICACY AS A SEALANT: Intra-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 drop in hemoglobin (1 gm% = 300 ml) without hemodilution. Correlates with intra-operative blood transfusions. Correlates with post-operative blood transfusions.
Intra-operative
SECONDARY SAFETY: Post-operative blood loss requiring return to the operating room
30 days
SECONDARY SAFETY: Prolonged post-operative pancreatic leakage
30 days
At the completion of pancreatic resection, the cut surface of the pancreas is covered with two layers of Albu-Green solder and one layer of D-Albumin lamina, all welded with the laser. The 60 Watt custom 810nm diode laser, is set to deliver continuous energy with laser irradiation power of approximately 150 W/cm2 with a Fluence of 90 J/cm2. During soldering the tip of the custom hand piece with top hat beam profile is held 1-2 cm from the wound surface to generate a 5mm spot size. Albu-Green Solder is observed to convert from a liquid green state to a solid white crust when the laser is activated indicating the completion of welding and providing a visual cue to the operator. The amount of Albu-Green solder and size of the denatured albumin lamina used is documented. The total laser tissue welding time for the three layers and the laser tissue welding time in seconds per cm2 is documented.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Baylor CHI St. Luke's Medical Center
Houston, Texas, 77030, United States
Kleeff J, Diener MK, Z'graggen K, Hinz U, Wagner M, Bachmann J, Zehetner J, Muller MW, Friess H, Buchler MW. Distal pancreatectomy: risk factors for surgical failure in 302 consecutive cases. Ann Surg. 2007 Apr;245(4):573-82. doi: 10.1097/01.sla.0000251438.43135.fb.
Goh BK. Re: Distal pancreatectomy: risk factors for surgical failure in 302 consecutive cases. Ann Surg. 2008 Feb;247(2):392-3; author reply 393. doi: 10.1097/SLA.0b013e318164022d. No abstract available.
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
11 participants (actual enrollment reported by the registry).
First Submitted
May 8, 2017
First Posted
May 10, 2017
Study Start
January 1, 2018
Actual (reported)Selective Transvenous Chemoembolization of Primary Pancreatic Tumors
SECONDARY SAFETY: Surgical space abscess
30 days
SECONDARY EFFICACY: Total operating time (minutes)
Intra-operative assessment
SECONDARY EFFICACY: Pancreas clamp time (minutes)
Intra-operative assessment
SECONDARY EFFICACY: Laser tissue welding time or time to hemostasis (Duration Metric)
Intra-operative assessment
Contact the study team to confirm eligibility.
Kazanjian KK, Hines OJ, Duffy JP, Yoon DY, Cortina G, Reber HA. Improved survival following pancreaticoduodenectomy to treat adenocarcinoma of the pancreas: the influence of operative blood loss. Arch Surg. 2008 Dec;143(12):1166-71. doi: 10.1001/archsurg.143.12.1166.
Shrikhande SV, D'Souza MA. Pancreatic fistula after pancreatectomy: evolving definitions, preventive strategies and modern management. World J Gastroenterol. 2008 Oct 14;14(38):5789-96. doi: 10.3748/wjg.14.5789.
Primary Completion
December 31, 2021
Actual (reported)Study Completion
December 31, 2021
Actual (reported)Last Updated
April 6, 2022
Record last verified: 2022-04
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Source: ClinicalTrials.gov.
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