EndoClot PHS A medical application on 74 patients march 2013

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1 EndoClot PHS A medical application on 74 patients march 2013

2 EndoClot PHS as a new method to achieve hemostasis of gastrointestinal bleeding Evaluation of a medical application involving 74 patients. Introduction EndoClot PHS (polysaccharide hemostasis system) is a novel product to achieve hemostasis in cases of gastrointestinal bleeding. It can be applied both in the upper and lower gastrointestinal tract to achieve hemostasis and bleeding prophylaxis. Endoclot PHS is based on AMP particles (absorbable modified polymer), which are made of a modified polysaccharide, are 100 percent resorbable and biocompatible. The AMP particles which are manufactured from plant starch are not pyrogenic, they are free of animal or human components. EndoClot PHS consists of a container with AMP particles and an application system which can be delivered through the working channel to the bleeding site under endoscopic control. The system is connected to an external air-compressor (EPAC-1), which guarantees a continuous, constant air-flow through the application catheter. This is how the AMP particles are transported through the catheter to the site of the under endoscopic control. EndoClot PHS is a CE-certified medical device and fulfills the requirements of the Medical Devices Directive 93/42/EEC. Background AMP particles have been used for several years successfully in open surgery to achieve hemostasis. In this application, the AMP particles immediately take up water from the blood, increase the concentration of the coagulation factors, and accelerate the regular physiological coagulation cascade. Mixed with blood, they form a gelatinous adhesive matrix which adheres to the bleeding site. The AMP particles decompose within a period of 1-48 hours and can be flushed off with water at any time under endoscopic view. The application of AMP particles in gastroenterology is authorized since September 2011 and available in Europe since Fields of Application EndoClot PHS has been developed to achieve hemostasis of gastrointestinal s, particularly of large-surface oozing and ulercerative s as well as s subsequent to interventions, e.g. EMR, ESD and polypectomy. The application of EndoClot as monotherapy is contraindicated in cases of arterial spurting s and Forrest-type 1a s. Description/Goal The application on 74 patients in different medical centers was to prove the efficacy of Endo- Clot in the hemostasis of non-varicose bleeding in the upper and lower gastrointestinal tract. EndoClot was applied as monotherapy or in addition to established hemostatic methods, such as clipping, injection, electrocoagulation, APC. The decision was at the discretion of the participating physician. Exclusion Criteria Application of EndoClot as monotherapy in patients with spurting bleeding and Forrest-type 1a bleeding due to peptic gastric ulcers, as well as patients with bleeding esophageal varices.

3 Methods All participating centers were instructed on how to use EndoClot PHS (polysaccharide hemostasis system) before onset of the study. The data was documented on a double-page evaluation sheet and included patient data such as age, sex, disease, hemorrhagic situation and location, clinical parameters, and information on followup procedures. The hemorrhagic situation was categorized on a scale from 1 to 4 (1 minimally diffuse, 2 extremely diffuse, 3 minimally spurting, 4 extremely spurting). Apart from peptic ulcers, diffuse and tumorous s, EndoClot was also applied in the treatment of s subsequent to interventions such as EMR, ESD, polypectomy and biopsy. EndoClot was also preventively applied as bleeding prophylaxis in some cases. Indication, mode (mono- or additive therapy) of EndoClot application was at the discretion of the study physician. The decision depended on the prevailing bleeding situation and the experience of the study physician, and pursued the objective of achieving a quick as possible stabilization of the bleeding situation with a sufficient degree of hemostasis. The respective follow-up of the patients was also the responsibility of the study physician in charge of therapy and depended on vital signs, laboratory parameters (HB/HK), and indications of hematin vomiting or melena. The evaluation included both patients with and without therapy with anticoagulant agents (e.g. heparin) in EndoClot treatment. No exclusion criterion existed for a treatment with EndoClot with regard to an evidently pathological Quick's value and/or PPT. Treatment with EndoClot was not considered as successful whenever a recurrent bleeding appeared in either group (monotherapy/additive therapy) within a period of 24 hours, which had to be treated with an established endoscopic procedure in order to attain sufficient hemostasis. The evaluation sheets were analyzed by employees of Micro-Tech Europe GmbH. Result of Evaluation In a period lasting from July till December 2012 a total of 74 patients (48 m / 26 f) aged years (median age: 71 years) from 24 participating centers were included in the multicentric evaluation. A successful hemostasis with Endo- Clot in all included patients was achieved in 88% (65 out of 74) of the cases. A successful primary hemostasis (monotherapy) with Endo- Clot was achieved in 85% (34 out of 40) of the cases. A successful hemostasis by an additive therapy using EndoClot was achieved in 91% (31 out of 34) of the cases. The respective distribution of hemorrhagic localizations was determined as follows: Upper GI s were localized by endoscopy in 81% (60 out of 74) of all cases. A lower GI appeared in 19% (14 out of 75) of all cases. One patient with an ischemic ulceration and a recurrent after 32h at another localization than the site treated with EndoClot had to undergo surgery. One patient with an Ulcus Dieulafoy's lesion under ASA therapy could not be successfully treated with EndoClot and was treated with metal clips instead.

4 In the monotherapy group, catheter occlusions and a premature termination of EndoClot -treatment occurred in two patients at one center; once after EMR, and once because of a peptic ulceration. One EndoClot treatment not classified as successful due to recurrent s occurred in each of the groups "peptic ulceration", "tumor ", and "diffuse ". The documented recurrent in the peptic ulceration group was ultimately treated with clips. The coagulation parameters in this patient were evidenced as pathological. The success rates of EndoClot after indication in the monotherapy group can be summarized as follows: 80% after EMR (4 out of 5), 100% after ESD (1 out of 1), 100% after polypectomy (3 out of 3), 100% after biopsy (7 out of 7), 60% in cases of peptic ulcerations (3 out of 5), 87,5% in cases of tumor (7 out of 8), and 90% in cases of diffuse s (9 out of 10). Monotherapy Indication acc. to Hemorrhage Localization Indication EMR ESD Polypectomy Biopsy Peptic ulceration Tumor Diffuse Dieulafoy's lesion Ischemic yes no Success in % Esophagus Upper third Middle third % Lower third % Stomach Fundus ,7% Corpus ,0% Antrum ,3% Duodenum Bulbus % Pars descendens % Papilla major % Pars ascendens Colon Rectum % Sigma ,0% Descendens % Transversum % Ascendens Cecum % T. Ileum Successful Not successful Success in % 80% 100% 100% 100% 60% 87,5% 90% 0% 85% Total % Patients: 34 Male: 21 Female: 13

5 There has been a total of 3 recurrences in the additive therapy group treated with EndoClot. One recurrent was documented in the ESD group (1 out of 5) which was treated with clip and fibrin. One recurrent also appeared in the EMR group within the follow-up period of 24 hours, which the study physician was able to treat successfully with EndoClot this time. There has been one documented recurrent in the group of peptic ulcerations which was treated surgically by a BII operation. The rates of success after indication in the additive therapy group can be summarized as follows: 83% after EMR (5 out of 6), 80% after ESD (4 out of 5), 100% in cases of polypectomy (3 out of 3), 100% after peptic ulcerations (10 out of 10), 100% in cases of tumor-related s (3 out of 3) and 100% in cases of diffuse s (6 out of 6). Additive Therapy Indication acc. to Hemorrhage Localization Indication EMR ESD Polypectomy Biopsy Peptic ulceration Tumor Diffuse Dieulafoy's lesion Ischemic yes no Success in % Esophagus Upper third Middle third Lower third ,5% Stomach Fundus % Corpus ,4% Antrum Duodenum Bulbus % Pars descendens % Papilla major % Pars ascendens Colon Rectum % Sigma % Descendens Transversum % Ascendens Cecum T. Ileum Successful Not successful Success in % 83,3% 80% 100% 100% 100% 100% 0% 91,2% Total ,2% Patients: 34 Male: 21 Female: 13

6 Summary The analysis of 74 evaluation sheets of a multicentric observational study on EndoClot applied in the clinical setting revealed a success rate of 88% for all patients and thus very promising results. The rate of success of a purely monotherapeutic application of 85%, as compared to 91.2% when EndoClot was applied in addition to established hemostatic methods suggest that EndoClot is particularly effective as an additive hemostatic agent. The application of EndoClot is safe and easy to perform. No side effects have been documented over the observation period. The only complications documented were catheter occlusions which occurred in 2 patients at one center. No catheter occlusions were documented at the other 23 centers. Acknowledgement We would like to thank all participating centers that participated in this multi-center evaluation and Dr. M. Philipper for his support in preparing this paper. EndoClot Plus, Inc Great America Parkway Suite 526 Santa Clara CA USA Phone: +1 (408) Fax: +1 (408) info@endoclot.com Specifications are subject to change without notice. 02/2013

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