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Cushioning Endoscopic Bite Block for Comfort and Positioning

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What is being tested

Novel Bite Block

Device
Who is being recruted

Digestive System Diseases

+ Gastrointestinal Diseases
+ Stomach Diseases
Over 18 Years
See all eligibility criteria
How is the trial designed

Device Feasibility Study

Interventional
Study Start: July 2025
See protocol details

Summary

Principal SponsorUniversity of Pennsylvania
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: July 1, 2025Actual date on which the first participant was enrolled.

This clinical trial is focused on evaluating a new type of bite block used during endoscopic procedures. An endoscopic bite block is a device that helps keep a patient's mouth open while a doctor uses a scope to look inside their body. The main goal is to see if this new version, which includes a soft, cushion-like addition, is more comfortable for patients and stays in place better than traditional bite blocks. This is important because a more comfortable bite block can make the procedure less unpleasant for patients and reduce the risk of it moving out of place during movements like yawning. In the study, participants will use the novel endoscopic bite block during their procedures. Researchers will observe how well it stays in place and how comfortable it feels for the patients, especially compared to the standard versions. The study aims to see if the new design offers better cushioning for teeth, which could lead to improved experiences during endoscopic examinations. While the study focuses on comfort and positioning, there are no specific risks or benefits mentioned aside from the potential for a more pleasant procedure experience.

Official TitleNovel Endoscopic Bite Block 
NCT06958250
Principal SponsorUniversity of Pennsylvania
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
10 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Device Feasibility Study
These studies test whether a new medical device (like a tool or piece of equipment) is safe and practical to use. They're usually small and focus on how the device works rather than how well it treats a condition.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Criteria

Inclusion Criteria 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, \> 18 years of age 4. Deemed appropriate for scheduled upper endoscopy by endoscopy and anesthesia staff Exclusion Criteria: 1. Known allergic reactions to components of the novel endoscopic bite block

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Patients will utilize the novel Bite Block during routine endoscopic procedure

Patients to utilize novel bite block during routine endoscopic procedures
Study Objectives
Primary Objectives

Documented on procedure survey
Secondary Objectives

Documented on procedure survey

Documented on procedure survey

Documented on procedure survey

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available. 
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