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This feasibility study aims to assess the safety and effectiveness of the Novel Endoscopic Bite Block. The device will be utilized in subjects undergoing routine outpatient upper endoscopy. The investigator hypothesizes that its innovative design will reduce complications associated with bite block positioning, thereby improving procedural efficiency and patient safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Novel Bite Block | Experimental | Insertion of Novel Endoscopic Bite Block in the subject's mouth following the usual manner prior to endoscopic procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novel Bite Block | Device | The endoscopist will utilize the Novel Endoscopic Bite Block for the duration of the upper endoscopy (single-use, disposable). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Successful completion of upper endoscopy procedures with the Novel Endoscopic Bite Block accessory | Proportion of endoscopic procedures that are successfully completed | Day of procedure |
| Absence of dental injury during the upper endoscopy | Number and type of dental injuries occurred during the upper endoscopy | Day of procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopist's satisfaction with lack of bite block movement | Proportion of endoscopic procedures assessed by the endoscopist as satisfactory | Day of procedure |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Anish Sheth, MD, AGAF | Penn Medicine Princeton Health | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn Medicine Princeton Health | Plainsboro | New Jersey | 08536 | United States |
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| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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