50 Participants Needed

Novel Bite Block for Endoscopy

MS
SS
Overseen BySheryl Smolensky, RN, MSN, OCN
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Pennsylvania
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new bite block for upper endoscopy procedures to determine if it can enhance safety and efficiency. The bite block aims to reduce complications associated with positioning regular devices. Individuals scheduled for a routine upper endoscopy, without allergies to the bite block material, might be suitable candidates for this study. Participation could help improve endoscopy procedures for everyone.

As an unphased trial, this study provides an opportunity to contribute to advancements in medical procedures that could benefit many patients in the future.

What prior data suggests that this bite block is safe for endoscopy?

Research shows that bite blocks, like the one being tested, are generally safe for use during endoscopies. Although specific data on this new bite block is not yet available, similar devices have demonstrated safety. For instance, studies on other bite blocks have found them well-tolerated, with few issues reported. Dental problems during endoscopy are rare, occurring in about 1 in 300 cases, and can often be avoided with proper checks. This suggests that the new bite block could offer a safe and comfortable experience for patients.12345

Why are researchers excited about this trial?

The Novel Endoscopic Bite Block is unique because it offers a new way to protect a patient's teeth and airway during endoscopy. Unlike standard bite blocks that are often cumbersome or uncomfortable, this novel device is designed for a more comfortable fit and easier insertion. Researchers are excited about this trial because improving patient comfort and safety during endoscopic procedures could make the experience more pleasant and efficient for both patients and healthcare providers.

What evidence suggests that this bite block is effective for endoscopy?

Research has shown that endoscopic bite blocks, such as the Novel Endoscopic Bite Block in this trial, help prevent patients from biting the endoscope or their tongue during procedures. Studies have found that these bite blocks reduce the need for doctors to manually adjust the equipment, making the procedure smoother and safer for patients. They also lower the risk of dental injuries. In previous studies, doctors reported greater satisfaction when using bite blocks due to fewer positioning issues. These findings suggest that the Novel Endoscopic Bite Block could enhance efficiency and safety during endoscopies.56789

Who Is on the Research Team?

AS

Anish Sheth, MD, AGAF

Principal Investigator

Penn Medicine Princeton Health

Are You a Good Fit for This Trial?

This trial is for individuals scheduled for routine outpatient upper endoscopy, who can give informed consent and commit to the study's duration. They must be considered appropriate candidates by both endoscopy and anesthesia staff.

Inclusion Criteria

I have signed and dated the consent form.
I am willing and able to follow all study requirements.
I am cleared for an upper endoscopy by the medical team.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Insertion of Novel Endoscopic Bite Block in the subject's mouth prior to endoscopic procedure

Day of procedure
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Novel Endoscopic Bite Block

Trial Overview

The study is testing a Novel Endoscopic Bite Block during routine upper endoscopies. It aims to see if this new device can reduce complications from bite block use, making the procedure safer and more efficient.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Novel Bite BlockExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials
2,118
Recruited
45,270,000+

Citations

Clinical efficacy of COMBO endoscopy of oropharyngeal ...

An endoscopic bite block is typically used during gastroscopy to prevent patients from biting the endoscope and their tongue. However, this ...

Capnographic monitoring using a novel mainstream ...

Secondary outcomes included technical feasibility of EUS and ERCP with the use of this novel over-the-biteblock monitor. Results. In total, 250 ...

Cushioning Endoscopic Bite Block for Comfort and Positioning

Endoscopist satisfaction · Absence of dental injury during endoscopy · Decreased need for manual bite block securing during endoscopy.

Efficacy of an assistive guide tube for improved endoscopic ...

Guide tube-assisted endoscopy for procedures that require repeated endoscopic access is safer and more effective than conventional endoscopy.

a study protocol for a multicenter randomized controlled trial

This study aims to examine the efficacy and safety of the COMBO (capnography monitoring bite block oxygenation) endoscopy oropharyngeal airway ...

Study Details | NCT06958250 | Novel Endoscopic Bite Block

This study will feasibility and comfort of the novel endoscopic bite block that contains a compressible addition to the traditional endoscopic bite block ...

Dental trauma in endoscopy: A systematic review and ...

Dental complications occur in approximately 1 in 300 of upper endoscopy cases. These are easily preventable by pre-endoscopy screening.

Oxygenating Bite Block for Endoscopy (OBB Trial)

Studies have shown that a special mouthpiece called an oxygenating bite block can safely provide high levels of extra oxygen during endoscopic procedures.

Bite Block for Endoscopy Consumer Trends

Explore the dynamic Bite Block for Endoscopy market forecast, CAGR, market size, drivers, trends, and restraints. Discover key insights for ...