Summary of clinical data:
Clinical data summary information that was, in part, the basis for granting the de novo can be found on the Cook Medical website at CookMedical.com/HemosprayData.
Pittayanon R, Khongka W, Linlaman S, et al. Hemostatic powder vs standard endoscopic treatment for gastrointestinal tumor bleeding: a multicenter randomized trial. Gastroenterol. 2023;165(3):762–772.e2.
View Article »
Lau J, Pittayanon R, Kwek A, et al. Comparison of a hemostatic powder and standard treatment in the control of active bleeding from upper nonvariceal lesions : a multicenter, noninferiority, randomized trial. Ann Intern Med. 2022;175(2):171–178.
View Article »
Sung J, Moreea S, Dhaliwal H, et al. Use of topical mineral powder as monotherapy for treatment of active peptic ulcer bleeding. Gastrointest Endosc. 2022;96(1):28–35.
View Article »
Hussein M, Alzoubaidi D, O’Donnell M, et al. Hemostatic powder TC-325 treatment of malignancy related upper gastrointestinal bleeds: international registry outcomes. J Gastroenterol Hepatol. 2021. 2021;36(11):3027–3032.
View Article »
Hussein M, Alzoubaidi D, Lopez M-F, et al. Hemostatic spray powder TC-325 in the primary endoscopic treatment of peptic ulcer-related bleeding: multicenter international registry. Endoscopy. 2021;53(1):36–43.
View Article »
Hussein M, Alzoubaidi D, de la Serna A, et al. Outcomes of Hemospray therapy in the treatment of intraprocedural upper gastrointestinal bleeding post-endoscopic therapy. United European Gastroenterol J. 2020;8(10):1155–1162.
View Article »
Hookey L, Barkun A, Sultanian R, et al. Successful hemostasis of active lower GI bleeding using a hemostatic powder as monotherapy, combination therapy, or rescue therapy. Gastrointest Endosc. 2019;89(4):865–871.
View Article »
Alzoubaidi D, Hussein M, Rusu R, et al. Outcomes from an international multicenter registry of patients with acute gastrointestinal bleeding undergoing endoscopic treatment with Hemospray. Dig Endosc. 2020;32(1):96–105.
View Article »
Haddara S, Jacques J, Lecleire S, et al. A novel hemostatic powder for upper gastrointestinal bleeding: a multicenter study (the “GRAPHE” registry). Endoscopy. 2016;48(12):1084–1095.
View Article »
Chen Y, Barkun A. Hemostatic powders in gastrointestinal bleeding: a systematic review. Gastrointest Endosc Clin N Am. 2015;25(3):535–552.
View Article »
Appleby VJ, Hutchinson JM, Beckett CJ, et al. Use of the haemostatic agent TC-325 in the treatment of bleeding secondary to endoscopic retrograde cholangiopancreatography sphincterotomy. QJM. 2015;108(1):79–80.
View Article »
Masci E, Arena M, Morandi E, et al. Upper gastrointestinal active bleeding ulcers: review of literature on the results of endoscopic techniques and our experience with Hemospray. Scand J Gastroenterol. 2014;49(11):1290–1295.
View Article »
Sulz MC, Frei R, Meyenberger C, et al. Routine use of Hemospray for gastrointestinal bleeding: prospective two-center experience in Switzerland. Endoscopy. 2014;46(7):619–624.
View Article »
Tarantino I, Barresi L, Granata A, et al. Hemospray for arterial hemorrhage following endoscopic ultrasound -guided pseudocyst drainage. Endoscopy. 2014;46(S 01):E71.
View Article »
Smith LA, Stanley AJ, Bergman JJ, et al. Hemospray application in nonvariceal upper gastrointestinal bleeding: results of the survey to evaluate the application of Hemospray in the luminal tract. J Clin Gastroenterol. 2014;48(10):e89–e92.
View Article »
Holster IL, Kuipers EJ, Tjwa ET. Hemospray in the treatment of upper gastrointestinal hemorrhage in patients on antithrombotic therapy. Endoscopy. 2013;45(1):63–66.
View Article »
Chen YI, Barkun AN, Soulellis C, et al. Use of the endoscopically applied hemostatic powder TC-325 in cancer-related upper GI hemorrhage: preliminary experience. Gastrointest Endosc. 2012;75(6):1278–1281.
View Article »
Cooper DM, Norton B, Hawkes ND, et al. Hemostatic powder TC-325 as first-line treatment option for malignant gastrointestinal bleeding: a cost-utility analysis in the United Kingdom. Endoscopy. 2025;57(6):583–592. doi:10.1055/a-2495-2813.
View Article »
Shah ED, Law R. Valuing innovative endoscopic techniques: hemostatic powder for the treatment of GI tumor bleeding. Gastrointest Endosc. 2024;100(1):49–54.
View Article »
Barkun AN, Adam V, Lu Y, et al. Using Hemospray improves the cost-effectiveness ratio in the management of upper gastrointestinal nonvariceal bleeding. J Clin Gastoenterol. 2018;52(1):36–44.
View Article »
Beye B, Barret M, Alatawi A, et al. Topical hemostatic powder promotes reepithelialization and reduces scar formation after extensive esophageal mucosal resection. Dis Esophagus. 2016;29(6):520–527.
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