Haemostatic Powder

Supporting product documention.

EndoClot Quickstart Reference

How to use EndoClot PHS

EndoClot is a versatile, single-use powder for haemostasis indicated for acute bleeding as well as for prevention of post-endoscopic surgical bleeding in a prophylactic capacity.

It is the only haemostatic powder TGA registered for use in both upper and lower GI tract for arteriolar, venous and/or capillary bleeding.

The AMP particles are derived from potato starch and contain no animal or human components nor do they interfere directly with the clotting cascade. The particles are absorbable and have an exemplary safety profile with over 500,000 applications worldwide, including open surgical application, with no serious adverse events reported.

The delivery method is controlled and precise, with no “white-out” effect and the device can be used multiple times in the same patient, until the desired haemostasis is achieved.

EndoClot represents very good value for money for both private and public hospitals and is available for a broader variety of indications making it the obvious choice for bleeding management in everyday procedural situations as well as for more specialised procedures. EndoClot works well in conjunction with most other haemostasis methods making it an ideal part of the “toolkit’ for bleeding management and prevention.

How Does it Work

AMP® particles have a molecular structure that rapidly absorbs water from blood, causing a high concentration of platelets, red blood cells and coagulation proteins at the bleeding site which accelerates the physiologic clotting cascade. The interaction of AMP® particles with blood rapidly produces a gelled matrix that adheres to and seals the bleeding tissue. AMP® particles are readily dissolved by saline irrigation and are degraded rapidly by human enzymes.

Why Is an Air Compressor Required?

The air compressor is required to maintain a constant stream of air through the catheter at all times, preventing occlusion as the dry powder travels down the catheter towards the lesion. As the catheter is placed into very wet areas (endoscope channel and GIT lumen), there are many opportunities for moisture to enter the catheter. If the dry powder meets this moisture, then a clot will form in the catheter. Use of an air compressor eliminates this complication allowing peace of mind during the EndoClot application process. There is never a need to flush the catheter under normal operating conditions.

Acute Bleeding

In an acute bleeding situation, EndoClot is indicated for the management of arteriolar, venous and capillary oozing that may arise from tumors, ulcers and other lesions as well as those created from endoscopic surgical procedures such as biopsy, polypectomy, EMR and ESD.

In addition to general acute bleeding, clinical evidence clearly supports the use of EndoClot in the following situations:

Tumor bleeding¹
Patients with coagulopathies for a variety of reasons as well as those who will recommence blood thinner medication after their procedure²
Lesions that are difficult to access with more traditional methods of haemostasis
Management of bleeding which occurs during Endoscopic Mucosal Resection (EMR)³

Prophylaxis

EndoClot does not require an actively bleeding lesion for successful application and as such, it will adhere to any mucosal surface. Mounting and persuasive clinical evidence exists for the use of EndoClot after the completion of EMR, ESD or polypectomy with a view to preventing potential bleeds which may occur hours to days later.

Routine administration of Endoclot^TM prior to gastric endoscopic mucosal and submucosal dissection has been shown to significantly reduce the risk of delayed bleeding by approximately 30-75% in clinical studies.^4,5

[1]. D. Müller Cerbes, A Beek, A. Dormann: Hemostasis with Powder – Experience with EndoClot^® in Difficult GI Bleedings. Endoskopie Heute 2013 (26(4)):254-8;Li Mingfeng, Zhao Jianhua: Clinical Observation of 30 Cases in Treating Gastrointestinal Bleeding by AMP Absorbable Polysaccharide Hemostatic Particles with Endoscopic® Applicator; EndoClot^® PHS as a new Method to achieve Hemostasis of Gastro-intestinal Bleeding – Evaluation of a medical Application involving 74 patients

[2]. D. Müller Cerbes, A Beek, A. Dormann: Hemostasis with Powder – Experience with EndoClot^® in Difficult GI Bleedings. Endoskopie Heute 2013 (26(4)):254-8

[3]. Rui Huang, Yanglin Pan, Na Hui, Xueguang Guo, Linhui Zhang, Xianping Wang, Rongchun Zhang, Hui Luo, Xiong Zhou, Qin Tao, Zhiguo Liu and Kaichun Wu: Polysaccharide hemostatic system for hemostasis management in colorectal endoscopic mucosal resection. Digestive Endoscopy 2014 Jan;26(1):63-8 ; J Patel, M Bhuva, I Al Bakir, J Landy, S Beg, M Fullard, S Catnach, A Leahy. Watford : The use of EndoClot^® Therapy in the Endoscopic Management of Gastrointestinal Bleeding. Gut 2014;63:A50-A51

[4]. Hahn KY et al. J Gastroenterol Hepatol 2017; doi: 10.1111/jgh.13990. [Epub ahead of print]

[5]. Chedgy F et al. Gut 2016;65:A226.

More than an Effective Hemostatic Powder

EndoClot® Adhesive is the latest innovative haemostatic powder from EndoClot Inc which combines the convenience and effectiveness of a spray on powder with additional benefits, such as mucosal sealing and protection from acid and alkaline conditions in the GI tract, remaining in place for up to three days.

Refer to images above: Second photo shows gel-like EndoClot Adhesive clearly observable on the lesion 3 days after ESD compared to day 1 in the third photo.

Mucosal Sealant and Protectant

The new and exciting additional benefit of Adhesive is its ability to seal a bleeding wound. Adhesive makes contact with blood or other fluids and forms a tenacious gel which seals the wound and prevents further bleeding, allowing a clot to form.

When Adhesive is in place, it remains over the area for up to three days protecting it from irritant conditions found in the GIT. It is resistant to both acid and alkaline, protecting the damaged mucosa and allowing healing to occur faster.

Powder Hemostat for Acute Bleeds

EndoClot Adhesive is indicated for capillary, venous and arteriolar oozing in both the upper and lower gastrointestinal tract.

It is composed of synthetic, non-absorbable, hydrophilic particles.

Like the original EndoClot PHS, Adhesive is safe and effective for use in stopping acute bleeding from ulcers, tumors and minimally invasive endoscopic surgery along the entire gastrointestinal tract.

Uses the same anti-clogging delivery system as EndoClot PHS
Effectively stops oozing bleeds along the entire GI tract
Remains in place on the mucosa for up to three days
Faster mucosal healing
Reduces delayed bleeding

Innovative System Minimises Clogging and Avoids “White-Out”

The EndoClot delivery system involves an air compressor which delivers a constant stream of air, greatly reducing incidence of catheter occlusion due to moisture. There is no need to flush the scope channel with air prior to insertion of the catheter.

This constant stream enables a greatly reduced amount of air to be used at a very low pressure, removing the chance of any “white-out” effect and enabling immediate visualisation of the lesion and facilitating a clear view of the field for any further procedures to be carried out, if required.