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Spot
Request this product to experience its benefits to your practice. You may also place your order and request samples by calling 800-451-5797.Spot®
The first and only non-India-ink-based product for marking the GI tract.Description and Ingredients
SPOT is a specially formulated, biocompatible agent designed for endoscopically marking or "tagging" lesions in the GI tract. SPOT is a suspension containing highly purified, very fine carbon particles. The particles remain in the submucosal injection site creating a permanent mark. Each steam sterilized, non-pyrogenic syringe contains 5cc of the marker. The composition of SPOT is as follows:
• Water for Injection
• Glycerol
• Polysorbate 80
• Benzyl Alcohol
• Simethicone
• High Purity Carbon BlackIndication for Use
SPOT is indicated for endoscopically marking lesions (such as colon cancer and polyps) in the GI tract when the endoscopist anticipates the lesion will require surgical removal within 30 days.
Contraindications
SPOT is contraindicated in patients with a known hypersensitivity to any of the ingredients in the product.
Warnings and Precautions
Some settling of the carbon pigment is normal. The syringe should be shaken vigorously prior to loading the injection needle.
SPOT is a sterile single-use only product. Sterile unless damaged. Leakage of product may be evidence of damage. Do not use. Discard any unused product after the syringe has been opened. Although the material is non-toxic, the marker may stain clothing or porous materials.
When using a sclerotherapy needle in the colon, the needle should be inserted into the colon wall at an angle so that the beveled tip of the needle is entirely beneath the mucosa. If the needle is inserted perpendicular to the mucosa, there is a risk of penetrating the serosa and injecting the marker directly into the peritoneal cavity.
Side Effects
During the clinical study, no adverse effects or patient discomfort were reported with SPOT. However, any inadvertent injection of marker into the intraperitoneal space should be monitored closely for adverse reactions.
Directions for Use
A 25 gauge sclerotherapy needle with a needle length of 4mm or less is recommended for this procedure. IMPORTANT: Spot® syringe should be shaken vigorously for 15-20 seconds prior to loading the injection catheter. Examine the syringe to verify that the pigment is fully suspended. Then attach the syringe to the luer fitting on the needle. With the needle retracted, insert the catheter through the biopsy channel of the endoscope.
When the needle is properly positioned, insert the tip 30° - 45° tangentially into the submucosal space of the colon. CAUTION: Do not insert the needle perpendicular to the colon as this may lead to perforation of the serosa and injection of the marker directly into the peritoneal cavity!
Inject 0.5-0.75 ml of the marker into each injection site. This volume typically produces a mark on the colon measuring 1-2 cm in diameter. When properly placed there is an immediate black blush of the marker at the injection site. Observe for leakage of the marker into the colon lumen. If this occurs, stop the injection and cautiously insert the needle further into the submucosa.
A minimum of four marker injections is recommended, one in each of the four quadrants of the colon around the area of the lesion. This technique assures that at least one of the marks can be observed by the operating surgeon from the serosal side of the colon and, if another endoscopy is necessary, the lesion can be observed from inside the lumen as well.The maximum recommended dose is 8 ml per patient.
Storage and Shelf Life
Store the product at room temperature. The product has a shelf life of two years. The expiration date and the lot number are printed on the syringe label. Store the syringes in the canister provided with the syringe tips pointed upward. Do not store with the syringe tips pointing down. Storing the syringes with tips down may allow a portion of the pigment to settle into the narrow syringe outlet and prevent the pigment from being re-suspended.
Customer Service
GI Supply, 200 Grandview Ave.,
Camp Hill, PA 17011 * 1-800-451-5797
8:30am to 5:00pm EST Monday-FridayBibliography
1. Ponsky J, King J. Endoscopic marking of colon lesions. Gastrointest Endosc 1975; 22:42-3.
2. Lightdale CJ. India ink colonic tattoo: blots on the record (editorial). Gastrointest Endosc 1991; 37:99-100.
3. Salomon S, Berner JS, Waye JD. Endoscopic India ink injection: a method for preparation, sterilization and administration. Gastrointest Endosc 1993; 39:803-5.
4. Endoscopic Tissue Staining and Tattooing. ASGE Technology Assessment Status - Evaluation October, 1995.
5. Nizam R, Siddiqi N, Landas SK, et al. Colonic tattooing with India ink: benefits, risks and alternatives. Am J Gastroenterol 1996; 91:1804-8.
6. Shatz BA, Weinstock LB, Swanson PE, et al. Long-term safety of India ink tattoos in the colon. Gastrointest Endosc 1997; 45:153-6.
(EC REP)Diagmed Healthcare LTD. * Lumley Close
Thirsk, North Yorkshire, England * Y07 3TD
Tel: 01845 526660Spot is a trademark of GI Supply
Patent #'s 6280702, 6599496
(CE) 0459SPOTIFU.04
Request this product to experience its benefits to your practice. You may also place your order and request samples by calling 800-451-5797.