EnteroTracker® Instructions for Use

Indications for Use

The EnteroTracker® is a device for the collection of fluid/mucus from the upper gastrointestinal tract of adult and pediatric patients.

Precautions

No significant complications have been reported, and no known contraindications exist. Physicians should evaluate the patient’s ability to swallow a capsule and if any components of the EnteroTracker® may be problematic for the patient.

Patients should not eat for 2 hours and should not drink for one hour prior to the procedure. A patient may be unable to swallow the capsule because of gagging or may vomit after doing so. The patient may drink as much water as needed to prevent gagging during both swallowing and dwell time. Gagging upon retrieval of the string may occur. On rare occasions where the entire string is swallowed, no ill effects were identified.

The EnteroTracker® has not been evaluated for safety in the Magnetic Resonance (MR) environment. Prescribing physicians should be aware and notify patients that the device contains a stainless-steel ball which renders the patient incompatible with MRI testing until the ball has been expelled in the stool.

The device is intended for single use only and should be stored and transported in a dry environment.

European Union Notice: If any serious incident occurs in relation to the device, the user or patient should report the incident to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.

Description

The EnteroTracker® should be administered by a healthcare professional or other trained personnel and supervised by a physician.

The EnteroTracker® capsule is supplied in pouches, each pouch containing a single device. Also supplied with the device is a single piece of Tegaderm™ and a pH marker. The EnteroTracker® is a single use item. Store in a dry place.

The EnteroTracker® capsule allows physicians to collect biofluid samples from the upper gastrointestinal (GI) tract. The device is comprised of an ingestible capsule that contains a weighted ball and a highly absorbent nylon string (see Figure 1). The looped portion of the string is secured externally to the patient’s cheek with the supplied Tegaderm™.

Key functional elements of the EnteroTracker®:

ElementCompositionFunctionality
StringWoven nylonDeployed in the upper gastrointestinal tract to absorb mucosal fluid
CapsuleVegetarian cellulose or gelatinDeploys the string as it is swallowed
BallStainless steelWeights the capsule to help move it down the gastrointestinal tract when swallowed
Tegaderm™Adhesive patchSecures the proximal end of the string to the cheek after swallowing
pH StickWood, pH Indicating WaxAllows marking the string for pH zones after retrieval
Figure 1: Capsule Diagram

Figure 1. EnteroTracker® Capsule

The capsule is swallowed by the patient. The string unwinds from the capsule as it enters the patient’s upper GI tract, where it absorbs the biofluids of interest. The capsule dissolves in the stomach. The weighted ball is released, passes through the GI tract and is expelled naturally in the stool. After a period designated by the physician, the string is retrieved slowly through the mouth.

Figure 2: pH Marker

Figure 2. pH marker

The supplied pH marker is used to indicate the pH on the collected string sample to inform digestive region respective of string region. The pH marker is a wooden stick that is dipped into a pH indicating wax (see Figure 2) and allows the physician/technician to determine the string portion of interest. The string can then be analyzed for the cells, biofluids, and biological markers that have been absorbed and entrapped within the string.

The procedure is described in detail below.

Capsule Procedure

  1. Put on medical gloves and remove capsule from pouch.
  2. Unwind the proximal string from around the capsule without pulling more string out of the capsule.
  3. Wrap the proximal end of the pulled string around the patient’s finger once and instruct the patient to keep hold of the string.
  4. Instruct the patient to swallow the capsule with water with the string remaining wrapped around the patient’s finger. Instruct the patient to continue drinking water until the capsule has been swallowed.
  5. Secure the looped end of the string to the patient’s cheek with Tegaderm™ tape or other non-allergic tape. With a permanent marker, mark the string that lies on the corner of the patient’s mouth; this is the 0-cm mark.
  6. After this, the patient should not drink or eat anything until the string is removed. Water can be used to prevent gagging if needed.
  7. The string should remain in the patient’s upper GI tract for a period designated by the physician. During this time, prepare for string processing as needed for the specific processing application. Refer to additional documentation as needed.
Figure 3: Capsule Procedure

Figure 3. Capsule procedure steps.

String Processing

  1. Retrieve the vial containing the Buffer Solution provided with the EnteroTracker® from refrigerated storage. Record patient information on vial label.
  2. Prepare a surface for cutting the string by placing the Parafilm® (paper side up) and measuring tape or cutting board out flat on clean surface. Remove the paper from the Parafilm®.
  3. When the string has been in the patient for the recommended time (1 hour for esophageal sampling), untape the string from the cheek and ask the patient to open their mouth wide. Pull the string out of the mouth at a slow, even rate. This should take no more than 5 seconds.
  4. Lay the string out flat and straight on a clean surface.
    1. With the optional accessory kit: Lay out the Parafilm®. Align the 0-cm mark on the string with 0 cm on the tape measure.
    2. The optional cutting board can be used as an alternative to the Parafilm® and tape measure.
  5. Starting at 20 cm for children and 25 cm for adults, touch the string with the pH marker at approximately 2-cm intervals to identify the esophageal, gastric, and small intestinal sections of the string.
  6. The gastric section should turn red/orange (acid, pH <4), while all other sections should be yellow/green (alkaline, pH >7).

pH Marker Color Chart

0
1
2
3
4
5
6
7
8
9
10

Figure 4. pH Marker Color Chart

If pH marking does not show a clear pH change indicating the gastric section, use the following equations to calculate the length at which the esophageal section begins.

a. Equations for Esophageal Length (in cm):

  • i. Children: 5 + 0.252 × height (cm)
  • ii. Adults: 6.7 + 0.226 × height (cm)
  1. To harvest the esophageal section of the string, mark the beginning of the esophageal section 7 cm from the 0 cm mark made in Capsule Procedure point #5. Mark the end of the esophageal section at 2 cm from the beginning of the gastric section (pH <4). Use the included tweezers and scissors to cut the esophageal section of the string.
  2. Place the esophageal section of the string into the vial containing the Buffer Solution. Make sure the string is submerged.
  3. Once the string is in the Buffer Solution, secure the lid of the vial and flip the vial over 7-8 times. Assure that the string is once again submerged in the Buffer Solution at the bottom of the vial after flipping
  4. Place the tube in the provided sealable plastic bag and expel air from the bag before resealing..
  5. Discard the remaining portions of the string in an appropriate location.

NoteConfirm hours of operation with the lab prior to shipment. If storage of the sample is necessary prior to shipment, place samples in freezer until ready to prepare shipment. Sample must remain frozen throughout shipment.

Shipping

Blue Ice Shipping

  1. Clinical samples must be frozen for a minimum of 24 hours before shipping in the BluePaq container.
  2. The BluePaq container, 6 oz. ice packs and 3 oz. ice packs must be frozen for a minimum of 24 hours before shipping. Please pull the two internal 6 oz. ice packs out of the BluePaq container before placing into freezer.
  3. Place frozen buffer vials containing the clinical sample(s) into the BluePaq container.
  4. Insert the 2 larger ice packets into the internal sleeves of the BluePaq container.
  5. Add 1 small ice pack next to the clinical sample(s) inside the BluePaq container.
  6. Zip up the BluePaq container.
  7. Place the BluePaq container horizontally into the Styrofoam insulated container.
  8. Insert 4 smaller ice packs around the edges of the BluePaq container.
  9. Close the insulated container lid.
  10. Place the insulated container into the shipping box.
  11. Add necessary paperwork.
  12. Close and seal the container. If shipping pickup is delayed, place the box into a refrigerator or freezer until close to pick up time.
  13. Ship overnight to EnteroTrack Labs.
  14. Send an email to labs@enterotrack.com letting us know clinical samples are on their way.

Dry Ice Shipping

  1. Take necessary safety precautions when handling dry ice to prevent skin injury.
  2. Place clinical sample(s) into the insulated shipping box.
  3. Cover sample(s) with dry ice (at least 5 lbs) and close lid.
  4. Place insulated shipping box into the outer cardboard container.
  5. Place necessary paperwork on top of insulated shipping box.
  6. Record the approximate weight in kilograms (~2.2 lbs = 1 kg) of the dry ice on the dry ice label on the outside of the cardboard shipping container.
  7. Close and seal the container. If shipping pickup is delayed, place the box into a refrigerator or freezer until close to pick up time.
  8. Ship overnight to EnteroTrack Labs.
  9. Send an email to labs@enterotrack.com letting us know clinical samples are on their way.
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