IB-Stim Device for Delayed Gastric Emptying
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a device called IB-Stim to determine its effectiveness for adults with gastroparesis-like symptoms, a condition where the stomach empties slowly. The device uses small electrical currents to stimulate nerves and may relieve stomach pain and discomfort. The trial compares the effects of an active device against a non-active one to assess any real benefit. Individuals who frequently experience fullness, pain, or burning in the upper stomach area and have had these issues for at least six months might be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance future treatment options.
What prior data suggests that the IB-Stim device is safe for treating delayed gastric emptying?
Research has shown that the FDA has approved the IB-Stim device for treating stomach pain in teenagers with IBS, indicating it has passed crucial safety checks for that age group. Studies have found the IB-Stim to be safe and generally well-tolerated for this purpose.
Although researchers are still studying the device for use in adults with slow stomach emptying (gastroparesis), its FDA approval for a similar condition in teenagers suggests likely safety. No major safety issues have been reported for the device in its approved use, which is reassuring. This suggests that any side effects are probably mild and manageable, but monitoring adult responses remains important as research continues.12345Why are researchers excited about this trial?
Unlike the traditional treatments for delayed gastric emptying, such as dietary changes, medications like prokinetics, or even surgical interventions, the IB-Stim device offers a novel non-drug approach. The IB-Stim is unique because it uses Percutaneous Electrical Nerve Field Stimulation (PENFS), which provides gentle electrical stimulation to nerves in the ear to potentially improve gastric motility. Researchers are excited about this treatment because it targets the nervous system in a new way, offering hope for more effective symptom relief without the side effects associated with medications. Additionally, the non-invasive nature of this device makes it an appealing option for patients seeking alternatives to drugs or surgery.
What evidence suggests that the IB-Stim device is effective for delayed gastric emptying?
Research has shown that the IB-Stim device, which uses Percutaneous electrical nerve field stimulation (PENFS), yields promising results for certain conditions. For example, one study found that 59% of patients using IB-Stim experienced at least a 30% reduction in pain, compared to 26% in a group that did not use the device. In this trial, participants will receive either an active PENFS device or a control device that is inactive. While IB-Stim is primarily approved for treating stomach pain in teenagers with IBS, researchers are exploring its benefits for adults with symptoms like slow stomach emptying. The device stimulates nerves, potentially improving stomach function and reducing symptoms. Although data for adults with slow stomach emptying is limited, early results in similar areas are encouraging.14567
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either active or sham PENFS device stimulation
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- IB-Stim
How Is the Trial Designed?
2
Treatment groups
Active Control
Placebo Group
Participants in this arm have active PENFS device stimulation
Participants in this arm have inactive PENFS device
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Cleveland Clinic
Lead Sponsor
Citations
Gastric Electrical Stimulation for Refractory Gastroparesis - PMC
Gastric emptying studies performed before and after GES placement showed a significant improvement in gastric emptying, with a decrease in the ...
Effectiveness of Gastric Neurostimulation in Patients ... - PMC
Patients with gastroparesis have significantly delayed gastric emptying because of impaired nerve function. Gastric neurostimulation from Enterra Therapy ...
IB-Stim Efficacy
IB-Stim treatment resulted in at least a 30% improvement in worst pain at the end of 3 weeks in 59% (16/27) vs 26% (6/23) in the active and sham groups, ...
Neuromodulation With Percutaneous Electrical Nerve Field ...
This study is a double-blind, randomized, sham-controlled pilot study evaluating the efficacy of PENFS using IB-Stim in adult patients with GPLS. A secondary ...
Efficacy of Gastric Electrical Stimulation for Gastroparesis
Vomiting was decreased by 62% after GES implant in the European centers and by 45% in the US centers. In the European centers, the patients' TSS was decreased ...
Gastric Electric Stimulation for Refractory Gastroparesis - PMC
A recent review that included a pooled analysis of 7 studies of G-POEM for gastroparesis demonstrated 100% technical success, with clinical efficacy in 81.5% of ...
Safety Profile for IB-Stim
The FDA evaluated IB-Stim for safety in patients (11-18 years) with functional abdominal pain and IBS.
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