Spot® Endoscopic Marker

Helping You Win the Fight Against Colon Cancer

Supports Patient Safety and Quality Goals

  • Spot increases care coordination between Endoscopist and Surgeon
  • Improves visualization in laparoscopic procedures

Clinically-Proven and Society-Recommended

  • Align your clinical practice with established guidelines on the need for colonic tattooing
  • Clinically proven through more than 25 published studies

Easy-to-Use and Cost-Effective

  • Shake it.  Attach it.  Prime it.

Item #:

  • Spot (Box of 10): GIS-44
  • Spot Endoscopic Marker is a sterile carbon black suspension for endoscopically tattooing the GI tract.  It is approved for use as a medical device.
  • Each 5mL pre-filled syringe offers a Luer-Lock tip that connects to standard injection needles.
  • The premixed package eliminates the 10+ preparation steps nurses follow with commercial, do-it-yourself india inks.
  • Spot is terminally steam sterilized, and can be stored in GI procedure rooms as a medical device. The fluid path is sterile when connected to injection needles.
  • The 5mL syringes are sold in packs of 10

Spot is Clinically-Proven and Society-Recommended
India Ink tattoos for the GI tract have been used by Gastroenterologists since at least the 1950s when Sauntry et al first described them. Ponsky et al. further studied their ability to facilitate locating colonic lesions in 1975. Since that time, the interest in tattooing colon lesions has only grown.

Download Spot Clinical Evidence Summary

Spot Endoscopic Marker is supported by overwhelming clinical research

  • Clinically proven through more than 25 published studies
  • Clear value to endoscopists in clincal surveillance
  • Colorectal Surgeons and Proctologists find lesions faster in surgical localization

Society Clinical Practice Guidelines Call for Tattooing
Consistent clinical evidence has led leading global societies to call for tattooing colon lesions for future procedures.

  • “Colonoscopic tattooing is performed to enable future identification, at colonoscopy or surgery, of malignant lesions (proven or suspected), polypectomy, EMR, or ESD sites, difficult-to-detect polyps, or dysplastic areas. All such lesions, other than those definitely located in the cecum, adjacent to the ileocecal valve, or in the low rectum, should be tattooed.1” – ESGE 2017 Clinical Guideline: Colorectal Polypectomy and Endoscopic Mucosal Resection (EMR)
  • Tattooing of all lesions > 20mm and/or suspicious of cancer outside of the rectum and caecum should take place in 100% of cases following local trust guidance.”2 – BSG 2016 Clinical Guideline: Colonoscopy Key Performance Indicators
  • Lesions…should be marked with ample submucosal injection of carbon black [Spot] in 3 to 4 quandrants to ensure resection of the correct segment.”3
  • Tattooing is extremely important for intraoperative localization. Tattooing should be accomplished using suspended carbon black commercially-prepared for this product [Spot®]”4 – SAGES 2012 Clinical Guideline: Laparoscopic Resection of Curable Colon and Rectal Cancer

 

  1. Ferlitsch M. et al., Colorectal polypectomy and endoscopic mucosal resection (EMR): European society of gastrointestinal endoscopy (ESGE) clinical guidelines. Endoscopy. 2017: 49
  2. Rex DK, et al., Quality indicators for colonoscopy. Am J Gastroenterol. 2014 Dec. 81(1): 31-53
  3. SAGES. Guidelines for Laparoscopic Resection of Curable Colon and Rectal Cancer. 2012 Feb.
  4. ASGE Technology Committee. Endoscopic tattooing. Gastrointest Endosc. 2010 Oct;72(4):681-5.

 

What is Spot for?
Spot is indicated for tattooing or “marking” lesions in the GI tract. Although commonly used for the future identification of colon cancer at colonoscopy or surgery, there are also other use cases throughout the GI tract. Researchers have shown the use of tattooing in Barret’s Esophagus1, Gastric Ulcers2, Double Balloon Enteroscopy3, and pancreatic lesion marking4.

1. Shaffer RT, et al., India Ink Tattooing In the Esophagus. Gastrointest Ednosc. 1998; 47:257-60
2. Allam ME, et al., Posterior Wall Gastric Leiomyoma: Endoscopic Tattooing Facilitates Laparoscopic Resection. JSLS. 1998; 2:83-84
3. Nina A, and Orhan B. Endoscopic Tattooing of Small Bowel by Double-Balloon Endoscopy. Dig Endosc. 2013; 4(2):49-51
4. Newman NA, et al., Preoperative Endoscopic Tattooing of Pancreatic Body and Tail Lesions Decreases Operative Time For Laparoscopic Distal Pancreatectomy. Surgery. 2010; 148:371-7

Is Spot the same as India ink?
No, it is not. Spot Endoscopic Marker contains high purity, suspended carbon black particles in a ready-to-use, sterile, pre-filled syringe. Commercial India ink often contains impurities such as shellacs, phenols, ammonia and animal products. According to an ASGE technology report, these impurities have been associated with complications such as inflammatory reactions. In a 113 patient study of Spot, no inflammation, fever or abdominal pain was detected in any of the patients. Why take the risk of do-it-yourself commercial India inks when you have a sterile, ready-to-use, FDA cleared solution.

Is Spot sterile?
Yes, Spot is terminally steam sterilized. It can be stored in normal conditions in GI procedure rooms, and offers a sterile fluid path when connected to a standard injection needle. Spot goes a step further to not contain shellac, phenols or ammonia like other sterile India-ink products.

Is Spot FDA cleared?
Yes, Spot received FDA clearance as a medical device for tattooing lesions in the GI tract.
Read the FDA 510(k) premarket notification to learn more

Do I have to combine and mix the ingredients of Spot?
No. Spot is packaged in a pre-filled, ready-to-use syringe. It’s luer-lock connection works with any standard injection needle to reduce the risk of spills, stains, and needle-stick injuries. With a quick shake to disperse the carbon particles, the syringe is ready to use.
Download Our Spot® Getting Started Guide to learn more

How do I inject Spot?
0.5-0.75ml of Spot should be injected submucosally into four quadrants distal to the lesion of interest. Use a 23 or 25 gauge injection needle 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.
Download the Spot Instructions for Use (IFU) to learn more

How do I store Spot?
Spot can be stored at room temperature, with the syringe tips pointing up, for up to two years. Most facilities store Spot directly in the GI procedure room, to ensure it’s available when you need it.

How do I order Spot?
Spot is available in boxes of 10 pre-filled syringes, as catalog number GIS-44. Give us a call or complete the GI Supply Orders Form and send it to customer service via e-mail or fax.

Need something else? Call (800) 451-5797 or fill out our online Contact Us form to request more information.

Spot® Endoscopic Marker is covered by the following U.S. patent numbers: 6280702, 6599496

Give us a call or send an email/fax to our Customer Service team.

Call (800) 451-5797 (8:30am – 5:00pm EST Monday – Friday)

E-mail orders@gi-supply.com

Fax (717) 761-0216

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