Information for Patients About a Clinical Trial
Hello. Thank you for taking a few minutes of your time to read about what G-Tech is working on to help your physician diagnose functional gastrointestinal (GI) disorders in the future! Functional GI disorders cause symptoms in people that are not caused by any structural problem. Some symptoms of a functional GI disorder include pain with bloating, constipation, and/or diarrhea. Functional disorders are not life-threatening nor serious diseases, but they can significantly alter one’s quality of life.
Millions of patients seek doctor care annually for various symptoms of the digestive system, including chronic abdominal pain, diarrhea, constipation, and bloating. Very often, the problems are functional in nature, which means that they cannot be attributed to any structural problem. Most tests now available to the physician are unable to detect any functional abnormality. G-Tech is a startup company in the medical device field, located in Palo Alto, CA. We are developing a means of measuring what your intestines are doing by sensing the electrical signals they produce while mixing or propelling their contents. Our premise, based on published data, is there is indeed a difference in the overall patterns of these signals between normal and patients with symptoms of a functional disorder. By measuring the patterns we hope to provide useful information to the physician to assist in determining the appropriate course of treatment of the patient. This will enable them to positively diagnose the functional problem, and then to objectively evaluate the effectiveness of any prescribed therapy. The data collected in this study will ultimately aid in the development of a device that will be used to record electrical rhythms in patient’s GI tract that will contribute to the appropriate treatment of functional disorders in the future. This trial does not provide you with any treatment, and this trial does not provide your doctor with a definitive diagnosis.
We are currently enrolling individuals who volunteer to participate in an IRB (Institutional Review Board) approved clinical study to gather data on the normal electrical patterns of healthy individuals and those with the symptoms we discussed. The data gathered will enable us to establish what the patterns are for these two groups. If you choose to participate in the study, you will be making a contribution to basic medical knowledge, with the goal to have a device available to all physicians and potentially helping many patients in the future.
Individuals Who Might be Candidates
We are looking for people who experience abdominal pain on a regular basis, whether with constipation, diarrhea, with other symptoms or pain without other symptoms. You will recline relatively still in a comfortable chair for at least 3 hours. You must be able to go without food, or any caffeine or sugar containing drink for 4 hours prior to the procedure, and you must eat a meal supplied during the study. The meal contains approximately 700 Calories with a balance of fats, protein and carbohydrates as recommended by our physician advisors. The typical meal consists of two very small (“slider”) chicken sandwiches and a 12 oz. milkshake. For those with gluten or lactose intolerance, or who are vegetarian, we have additional options which match the nutritional values.
You will need to be able to have ECG electrodes placed on your skin, which are the sticky patches used when your heart rhythm is assessed.
Individuals Who Are NOT Candidates
You may not participate if you have a pacemaker or ICD, or any other implanted automated device such as an insulin pump or a pump that administers analgesia, or if you weigh over 300 lbs.
What Your Experience Will Be Like
Standard ECG electrodes will be placed on your abdomen in 3 rows of ten electrodes, about 2” apart from one another, centered around your belly button. These electrodes are used only to sense the tiny electrical currents from your GI organ. You will not feel them except for placement on the skin and removal.
Once the electrodes are attached you will sit in a comfortable reclining chair for the duration of the test. We ask that you permit the recording of data for at least 3 hours. You will be asked to keep your movements to a minimum during data recording. It is normal and acceptable to occasionally shift one’s position, or cross or uncross one’s legs.
To help pass the time during the test you will be set up with an iPad or notebook computer and Netflix, or you may bring your own source of video or music. Reading and/or working on a computer compromises the data quality so is not allowed. Similarly it is best to limit conversation during the test, so phone calls are not allowed.
Prior to the beginning of the test you should have had nothing to eat for at least 4 hours, nor any caffeine or drinks with sugar. Exactly one hour into the test you will consume the meal that we provide. The meal will stimulate your GI tract to the proper degree for the test’s purposes. Just as an ECG of your heart records the electrical signals corresponding to its beating, the electrodes placed on your belly will allow the recording of the signals from your GI tract as it reacts to the meal.
Once the test is complete we will remove the electrode wires and you will peel off the electrodes. They are attached with a mild adhesive that not quite as sticky as a band-aid. Depending on your skin’s sensitivity you may notice some mild redness of the skin for the next few days. This is normal. If you are allergic to medical grade adhesives or the gel used in ECG electrodes you may not participate. Most people are not allergic to either.
The test will be held at G-Tech's office at the Fogarty Institute for Innovation in Mountain View, CA. The test will be run by trained members of the G- Tech research staff. Generally we ask subjects to arrive at either 9am or 10am, but other times can be accommodated as well. The total elapsed time from your arrival to departure is typically under 4 hours.
If You Wish to Participate or Learn More
If you are interested in participating, or in learning more, please inform your doctor. You will receive a prompt phone call or email from a research staff member