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| Name | Class |
|---|---|
| American Gastroenterological Association | OTHER |
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To assess patient acceptance and preference among screening modalities, Esophagogastroduodenoscopy (EGD), Transnasal Esophagoscopy (TNE), and Cytosponge for Barrett's esophagus (BE). Subjects will undergo administration of Cytosponge and transnasal endoscopy (TNE) prior to their scheduled clinically indicated upper endoscopy performed per routine standard of care. Following the procedure, a follow-up phone call will be made during which an impact of events scale related to the subjective distress of each procedure, a preference and acceptance questionnaire, and adverse events related to study participation will be collected.
Potential subjects will be identified via protocol and Institutional Review Board (IRB) methods prior to obtaining written informed consent. Once written informed consent is obtained and baseline demographic and medical history is collected, subjects will undergo administration of Cytosponge and transnasal endoscopy (TNE) prior to their scheduled clinically indicated upper endoscopy performed per routine standard of care. Following the procedure, a follow-up phone call will be made during which an impact of events scale related to the subjective distress of each procedure, a preference and acceptance questionnaire, and adverse events related to study participation will be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TNE Followed by EGD | Experimental | Subjects will undergo administration of a transnasal endoscopy (TNE) prior to their scheduled clinically indicated upper endoscopy performed per routine standard of care. Following the procedure, a follow-up phone call will be made during which an impact of events scale related to the subjective distress of each procedure, a preference and acceptance questionnaire, and adverse events related to study participation will be collected. |
|
| Cytosponge, then TNE, followed by EGD | Experimental | Subjects will undergo administration of Cytosponge and transnasal endoscopy (TNE) prior to their scheduled clinically indicated upper endoscopy performed per routine standard of care. Following the procedure, a follow-up phone call will be made during which an impact of events scale related to the subjective distress of each procedure, a preference and acceptance questionnaire, and adverse events related to study participation will be collected. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cytosponge | Device | In a seated position, subjects will swallow the Cytosponge capsule with 150-250 mL of water. Seven minutes and 30 seconds to ten minutes after ingestion, the sponge is then withdrawn by gentle traction on the suture. After retrieval, the string is cut and the retrieved foam sphere containing the cytological specimen is immersed in fixative and stored refrigerated (1° to 12°C [34° to 54°F]). |
| Measure | Description | Time Frame |
|---|---|---|
| 7 Days Post-EGD Impact of Events Score (IES) | Impact of Events Score (IES): scale was developed to assess the distress associated with a specific life event. IES scores range from 0-75, with higher scores indicating more severe distress associated from an event. Scores ≥ 44 indicate a event has severe impact on self-reported distress while scores ≤ 25 indicate the event may have an effect on distress. | 7 days post-EGD |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) Score | Visual Analog Scale (VAS): 100-mm horizontal line on which the participant's pain intensity is represented by a point between the extremes of 0 reflecting "no pain at all" and 100 reflecting the "worst pain imaginable." | Day 1, Post-procedure (<24 hours of procedure completion) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Swathi Eluri, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | TNE Followed by EGD | Participants will undergo administration of a transnasal endoscopy (TNE) prior to their scheduled clinically indicated upper endoscopy performed per routine standard of care. Following the procedure, a follow-up phone call will be made during which an impact of events scale related to the subjective distress of each procedure, a preference and acceptance questionnaire, and adverse events related to study participation will be collected. Transnasal Endoscopy (TNE): In an upright position, the scope will be inserted via the nares to examine the posterior pharynx, esophagus and proximal stomach with the transnasal endoscopy approach. The scope will be withdrawn from the nares following completion of the exam. Esophagogastroduodenoscopy: Laying on the participants' left side, the flexible endoscope is inserted through the mouth to allow visualization of the esophageal mucosa from the upper esophageal sphincter all the way to the esophagogastric junction (EGJ). |
| FG001 | Cytosponge, Then TNE, Followed by EGD | Participants will undergo administration of Cytosponge and transnasal endoscopy (TNE) prior to their scheduled clinically indicated upper endoscopy performed per routine standard of care. Following the procedure, a follow-up phone call will be made during which an impact of events scale related to the subjective distress of each procedure, a preference and acceptance questionnaire, and adverse events related to study participation will be collected. Cytosponge: In a seated position, participants will swallow the Cytosponge capsule with 150-250 mL of water. Seven minutes and 30 seconds to ten minutes after ingestion, the sponge is then withdrawn by gentle traction on the suture. After retrieval, the string is cut and the retrieved foam sphere containing the cytological specimen is immersed in fixative and stored refrigerated (1° to 12°C [34° to 54°F]). Transnasal Endoscopy (TNE): In an upright position, the scope will be inserted via the nares to examine the posterior pharynx, esophagus and proximal stomach with the transnasal endoscopy approach. The scope will be withdrawn from the nares following completion of the exam. Esophagogastroduodenoscopy: Laying on the participants' left side, the flexible endoscope is inserted through the mouth to allow visualization of the esophageal mucosa from the upper esophageal sphincter all the way to the esophagogastric junction (EGJ). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants enrolled into the arm completing all 3 maneuvers (i.e., Cytosponge, Then TNE, Followed by EGD).
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| ID | Title | Description |
|---|---|---|
| BG000 | TNE Followed by EGD | Participants will undergo administration of a transnasal endoscopy (TNE) prior to their scheduled clinically indicated upper endoscopy performed per routine standard of care. Following the procedure, a follow-up phone call will be made during which an impact of events scale related to the subjective distress of each procedure, a preference and acceptance questionnaire, and adverse events related to study participation will be collected. Transnasal Endoscopy (TNE): In an upright position, the scope will be inserted via the nares to examine the posterior pharynx, esophagus and proximal stomach with the transnasal endoscopy approach. The scope will be withdrawn from the nares following completion of the exam. Esophagogastroduodenoscopy: Laying on the participants' left side, the flexible endoscope is inserted through the mouth to allow visualization of the esophageal mucosa from the upper esophageal sphincter all the way to the esophagogastric junction (EGJ). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 7 Days Post-EGD Impact of Events Score (IES) | Impact of Events Score (IES): scale was developed to assess the distress associated with a specific life event. IES scores range from 0-75, with higher scores indicating more severe distress associated from an event. Scores ≥ 44 indicate a event has severe impact on self-reported distress while scores ≤ 25 indicate the event may have an effect on distress. | All participants enrolled into the arm completing all 3 maneuvers (i.e., Cytosponge, Then TNE, Followed by EGD). | Posted | Mean | Standard Deviation | units on a scale | 7 days post-EGD |
|
From the time of informed consent through seven days post-intervention, a total of 8 days.
All procedures were completed sequentially during the same visit with study staff inquiring about the occurence of adverse events following completion of all procedures. Thus, determination of which particular device to which an event might be attributable is not possible.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TNE Followed by EGD | Participants will undergo administration of a transnasal endoscopy (TNE) prior to their scheduled clinically indicated upper endoscopy performed per routine standard of care. Following the procedure, a follow-up phone call will be made during which an impact of events scale related to the subjective distress of each procedure, a preference and acceptance questionnaire, and adverse events related to study participation will be collected. Transnasal Endoscopy (TNE): In an upright position, the scope will be inserted via the nares to examine the posterior pharynx, esophagus and proximal stomach with the transnasal endoscopy approach. The scope will be withdrawn from the nares following completion of the exam. Esophagogastroduodenoscopy: Laying on the participants' left side, the flexible endoscope is inserted through the mouth to allow visualization of the esophageal mucosa from the upper esophageal sphincter all the way to the esophagogastric junction (EGJ). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain - Throat/Esophageal | Gastrointestinal disorders | Systematic Assessment | Pain experienced in the throat/esophagus |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ariel E. Watts, Assistant Director of Clinical Trial Operations | UNC Center for Esophageal Diseases & Swallowing | 919-962-7316 | ariel_watts@med.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 16, 2021 | May 4, 2023 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D019723 | Endoscopes |
| D016145 | Endoscopy, Digestive System |
| ID | Term |
|---|---|
| D019719 | Diagnostic Equipment |
| D004864 | Equipment and Supplies |
| D013523 | Surgical Equipment |
| D003938 | Diagnostic Techniques, Digestive System |
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|
|
| Transnasal Endoscopy (TNE) | Device | In an upright position, the scope will be inserted via the nares to examine the posterior pharynx, esophagus and proximal stomach with the transnasal endoscopy approach. The scope will be withdrawn from the nares following completion of the exam. |
|
|
| Esophagogastroduodenoscopy | Device | Laying on the subjects' left side, the flexible endoscope is inserted through the mouth to allow visualization of the esophageal mucosa from the upper esophageal sphincter all the way to the esophagogastric junction (EGJ). |
|
|
| 7 Days Post-EGD Willingness to Repeat |
7 days post-EGD participants were asked about their willingness to repeat the maneuvers (Yes/No). |
| 7 days post-EGD |
| 7 Days Post-EGD Ranking of Preferred Screening Modality | Participants asked to rank preferred screening modality in order (1,2,3). Scores range from 0-3. Scores of 1 indicate a preference, while scores of 3 indicate aversion. | 7 days post-EGD |
| Number of Participants Reporting Preferred Screening Modality | Participants asked "Which procedure would you prefer to undergo again?" Only one item could be selected. | 7 days post-EGD |
| Factors Influencing the Preferred Screening Modality | Participants asked what factors influenced preference in choosing preferred screening modality. Selection options were: discomfort/pain; time (preparation time and post-procedure); cost; and sedation. Participants could provide multiple response selections. | 7 days post-EGD |
| BG001 | Cytosponge, Then TNE, Followed by EGD | Participants will undergo administration of Cytosponge and transnasal endoscopy (TNE) prior to their scheduled clinically indicated upper endoscopy performed per routine standard of care. Following the procedure, a follow-up phone call will be made during which an impact of events scale related to the subjective distress of each procedure, a preference and acceptance questionnaire, and adverse events related to study participation will be collected. Cytosponge: In a seated position, participants will swallow the Cytosponge capsule with 150-250 mL of water. Seven minutes and 30 seconds to ten minutes after ingestion, the sponge is then withdrawn by gentle traction on the suture. After retrieval, the string is cut and the retrieved foam sphere containing the cytological specimen is immersed in fixative and stored refrigerated (1° to 12°C [34° to 54°F]). Transnasal Endoscopy (TNE): In an upright position, the scope will be inserted via the nares to examine the posterior pharynx, esophagus and proximal stomach with the transnasal endoscopy approach. The scope will be withdrawn from the nares following completion of the exam. Esophagogastroduodenoscopy: Laying on the participants' left side, the flexible endoscope is inserted through the mouth to allow visualization of the esophageal mucosa from the upper esophageal sphincter all the way to the esophagogastric junction (EGJ). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Cytosponge | Participants will undergo administration of Cytosponge. Cytosponge: In a seated position, participants will swallow the Cytosponge capsule with 150-250 mL of water. Seven minutes and 30 seconds to ten minutes after ingestion, the sponge is then withdrawn by gentle traction on the suture. After retrieval, the string is cut and the retrieved foam sphere containing the cytological specimen is immersed in fixative and stored refrigerated (1° to 12°C [34° to 54°F]). |
| OG002 | Transnasal Endoscopy (TNE) | Participants will undergo administration of TNE. Transnasal Endoscopy (TNE): In an upright position, the scope will be inserted via the nares to examine the posterior pharynx, esophagus and proximal stomach with the transnasal endoscopy approach. The scope will be withdrawn from the nares following completion of the exam. |
| OG003 | Esophagogastroduodenoscopy (EGD) | Esophagogastroduodenoscopy: Laying on the participants' left side, the flexible endoscope is inserted through the mouth to allow visualization of the esophageal mucosa from the upper esophageal sphincter all the way to the esophagogastric junction (EGJ). |
|
|
| Secondary | Visual Analog Scale (VAS) Score | Visual Analog Scale (VAS): 100-mm horizontal line on which the participant's pain intensity is represented by a point between the extremes of 0 reflecting "no pain at all" and 100 reflecting the "worst pain imaginable." | All participants enrolled into the arm completing all 3 maneuvers (i.e., Cytosponge, Then TNE, Followed by EGD). | Posted | Mean | Standard Deviation | units on a scale | Day 1, Post-procedure (<24 hours of procedure completion) |
|
|
|
| Secondary | 7 Days Post-EGD Willingness to Repeat | 7 days post-EGD participants were asked about their willingness to repeat the maneuvers (Yes/No). | All participants enrolled into the arm completing all 3 maneuvers (i.e., Cytosponge, Then TNE, Followed by EGD). | Posted | Count of Participants | Participants | 7 days post-EGD |
|
|
|
| Secondary | 7 Days Post-EGD Ranking of Preferred Screening Modality | Participants asked to rank preferred screening modality in order (1,2,3). Scores range from 0-3. Scores of 1 indicate a preference, while scores of 3 indicate aversion. | Preferred screening was inadvertently omitted during form creation and these data were not collected. | Posted | 7 days post-EGD |
|
|
| Secondary | Number of Participants Reporting Preferred Screening Modality | Participants asked "Which procedure would you prefer to undergo again?" Only one item could be selected. | All participants enrolled into the arm completing all 3 maneuvers (i.e., Cytosponge, Then TNE, Followed by EGD). | Posted | Count of Participants | Participants | 7 days post-EGD |
|
|
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| Secondary | Factors Influencing the Preferred Screening Modality | Participants asked what factors influenced preference in choosing preferred screening modality. Selection options were: discomfort/pain; time (preparation time and post-procedure); cost; and sedation. Participants could provide multiple response selections. | All participants enrolled into the arm completing all 3 maneuvers (i.e., Cytosponge, Then TNE, Followed by EGD). | Posted | Count of Participants | Participants | 7 days post-EGD |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Cytosponge, Then TNE, Followed by EGD | Participants will undergo administration of Cytosponge and transnasal endoscopy (TNE) prior to their scheduled clinically indicated upper endoscopy performed per routine standard of care. Following the procedure, a follow-up phone call will be made during which an impact of events scale related to the subjective distress of each procedure, a preference and acceptance questionnaire, and adverse events related to study participation will be collected. Cytosponge: In a seated position, participants will swallow the Cytosponge capsule with 150-250 mL of water. Seven minutes and 30 seconds to ten minutes after ingestion, the sponge is then withdrawn by gentle traction on the suture. After retrieval, the string is cut and the retrieved foam sphere containing the cytological specimen is immersed in fixative and stored refrigerated (1° to 12°C [34° to 54°F]). Transnasal Endoscopy (TNE): In an upright position, the scope will be inserted via the nares to examine the posterior pharynx, esophagus and proximal stomach with the transnasal endoscopy approach. The scope will be withdrawn from the nares following completion of the exam. Esophagogastroduodenoscopy: Laying on the participants' left side, the flexible endoscope is inserted through the mouth to allow visualization of the esophageal mucosa from the upper esophageal sphincter all the way to the esophagogastric junction (EGJ). | 0 | 24 | 0 | 24 | 3 | 24 |
|
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| D004066 |
| Digestive System Diseases |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| Title | Measurements |
|---|
|
| Sedation |
|
| Other |
|