Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-08390 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 15-004540 | Other Identifier | Mayo Clinic in Rochester | |
| P30CA015083 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Exact Sciences Corporation | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This study is being done to collect data on the potential use of a sponge on a string device as a non-invasive tool in evaluating patients with Barrett's Esophagus compared to healthy controls.
This study will be conducted in two phases: Phase 1 and Phase 2. Phase 1 will consist of determining the most optimal sponge on a string design (25 mm sponge 20 pores/inch or 25 mm sponge 10 pores/inch) chosen based on participant acceptance, tolerability, mucosal irritation and DNA yield, using a randomized factorial design pilot trial. Participants will first undergo the sponge on a string test followed by clinical endoscopy. Following completion of Phase 1 trial, the most optimal sponge on a string configuration will be chosen for Phase 2. Phase 2 will be conducted using a single size sponge with the same porosity configuration selected from Phase 1. Study procedures, testing and follow up will be the same as Phase 1.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1: Sponge on a String 25 mm 10 pores/inch | Experimental | In phase 1 of the study, subjects will be assigned to swallow a capsule sponge device 25 mm 10 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy |
|
| Phase 1: Sponge on a String 25 mm 20 pores/inch | Experimental | In phase 1 of the study, subjects will be assigned to swallow a capsule sponge device 25 mm 20 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy |
|
| Phase 2: Cases - Barrett's Esophagus | Experimental | In phase 2 of the study, additional subjects will be assigned to swallow a capsule sponge device 25 mm 10 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy |
|
| Phase 2: Controls - No Barrett's Esophagus | Experimental | In phase 2 of the study, additional subjects will be assigned to swallow a capsule sponge device 25 mm 10 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biopsy | Procedure | Undergo biopsy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects That Would Have This Procedure Again | Number of subjects that answered yes to the self-reported question "Would you choose to have this procedure again to screen for Barrett's esophagus?" | Within 24 hours of the capsule sponge administration |
| Tolerability of Swallowing the Sponge Device | Measured using a self-reported 5-item tolerability assessment rating discomfort during the procedure on a Likert scale of 0-10; 10 representing the "worst experience" and 0 the "best experience." This scale allows a comprehensive and individual assessment of the degree of pain, choking, gagging, anxiety and overall experienced during the procedure. | Within 24 hours of the capsule sponge administration |
| Mucosal Irritation | Measured using a mucosal injury score (ranging from 1=no trauma to 5=severe) was scored from video recordings of the subsequent endoscopy conducted | Within 24 hours of the capsule sponge administration |
| DNA Yield | Total amount of DNA obtained from esophageal cytology specimens collected by the capsule sponge devices. | Within 24 hours of the capsule sponge administration |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of Barrett's Dysplasia Detection | The sensitivity methylated DNA markers detected by the capsule sponge, in making a diagnosis of BE related dysplasia will be assessed using endoscopic surveillance biopsy histology as a gold standard. | Within 24 hours of the capsule sponge administration |
| Specificity of Barrett's Dysplasia Detection |
Not provided
Inclusion Criteria:
Subjects with known Barrett's Esophagus (BE).
Exclusion Criteria:
Subjects with known BE.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Prasad G Iyer, M.D. | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Scottsdale | Arizona | 85259 | United States | ||
| Mayo Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38513982 | Derived | Iyer PG, Slettedahl SW, Mahoney DW, Giakoumopoulos M, Olson MC, Krockenberger M, Taylor WR, Foote P, Berger C, Leggett C, Wu TT, Antpack E, Falk GW, Ginsberg GG, Abrams JA, Lightdale CJ, Ramirez F, Kahn A, Wolfsen H, Konda V, Trindade AJ, Kisiel JB. Algorithm Training and Testing for a Nonendoscopic Barrett's Esophagus Detection Test in Prospective Multicenter Cohorts. Clin Gastroenterol Hepatol. 2024 Aug;22(8):1596-1604.e4. doi: 10.1016/j.cgh.2024.03.003. Epub 2024 Mar 19. | |
| 33857451 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1: Sponge on a String 25 mm 10 Pores/Inch | In phase 1 of the study, subjects will be assigned to swallow a capsule sponge device 25 mm 10 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy Capsule Sponge Device 25 mm 10 pores/inch: Polyurethane foam sponge compressed in a vegetable material derived capsule, attached to a string. The capsule is swallowed by the patient. The shell of the capsule dissolves in the gastric fluid releasing the foam device as a sphere which is then pulled out with the attached string, providing brushing/cytology samples of the proximal stomach and esophagus. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| 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 | Apr 29, 2021 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Biospecimen Collection | Procedure | Undergo collection of blood sample |
|
|
| Endoscopic Procedure | Procedure | Undergo endoscopy |
|
|
| Swallowable Sponge Cell Sampling Device | Device | Undergo swallowable sponge cell sampling assessment |
|
|
The specificity of methylated DNA markers detected by the capsule sponge, in identifying subjects without a diagnosis of BE related dysplasia will be assessed using endoscopic surveillance biopsy histology as a gold standard. |
| Within 24 hours of the capsule sponge administration |
| Jacksonville |
| Florida |
| 32224 |
| United States |
| Mayo Clinic Health System - Mankato | Mankato | Minnesota | 56001 | United States |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| Northwell Health | Manhasset | New York | 11030 | United States |
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| Iyer PG, Taylor WR, Slettedahl SW, Lansing RL, Hemminger LL, Cayer FK, Mahoney DW, Giakoumopoulos M, Allawi HT, Wu TT, Wang KK, Wolfsen HC, Antpack E, Kisiel JB. Validation of a methylated DNA marker panel for the nonendoscopic detection of Barrett's esophagus in a multisite case-control study. Gastrointest Endosc. 2021 Sep;94(3):498-505. doi: 10.1016/j.gie.2021.03.937. Epub 2021 Apr 20. |
| 29891853 | Derived | Iyer PG, Taylor WR, Johnson ML, Lansing RL, Maixner KA, Yab TC, Simonson JA, Devens ME, Slettedahl SW, Mahoney DW, Berger CK, Foote PH, Smyrk TC, Wang KK, Wolfsen HC, Ahlquist DA. Highly Discriminant Methylated DNA Markers for the Non-endoscopic Detection of Barrett's Esophagus. Am J Gastroenterol. 2018 Aug;113(8):1156-1166. doi: 10.1038/s41395-018-0107-7. Epub 2018 Jun 12. |
| FG001 | Phase 1:Sponge on a String 25 mm 20 Pores/Inch | In phase 1 of the study, subjects will be assigned to swallow a capsule sponge device 25 mm 20 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy Capsule Sponge Device 25 mm 20 pores/inch: Polyurethane foam sponge compressed in a vegetable material derived capsule, attached to a string. The capsule is swallowed by the patient. The shell of the capsule dissolves in the gastric fluid releasing the foam device as a sphere which is then pulled out with the attached string, providing brushing/cytology samples of the proximal stomach and esophagus. |
| FG002 | Phase 2: Cases - Barrett's Esophagus | In phase 2 of the study, additional subjects will be assigned to swallow a capsule sponge device 25 mm 10 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy Capsule Sponge Device 25 mm 10 pores/inch: Polyurethane foam sponge compressed in a vegetable material derived capsule, attached to a string. The capsule is swallowed by the patient. The shell of the capsule dissolves in the gastric fluid releasing the foam device as a sphere which is then pulled out with the attached string, providing brushing/cytology samples of the proximal stomach and esophagus. |
| FG003 | Phase 2: Controls - No Barrett's Esophagus | In phase 2 of the study, additional subjects will be assigned to swallow a capsule sponge device 25 mm 10 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy Capsule Sponge Device 25 mm 10 pores/inch: Polyurethane foam sponge compressed in a vegetable material derived capsule, attached to a string. The capsule is swallowed by the patient. The shell of the capsule dissolves in the gastric fluid releasing the foam device as a sphere which is then pulled out with the attached string, providing brushing/cytology samples of the proximal stomach and esophagus. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1: Sponge on a String 25 mm 10 Pores/Inch | In phase 1 of the study, subjects will be assigned to swallow a capsule sponge device 25 mm 10 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy Capsule Sponge Device 25 mm 10 pores/inch: Polyurethane foam sponge compressed in a vegetable material derived capsule, attached to a string. The capsule is swallowed by the patient. The shell of the capsule dissolves in the gastric fluid releasing the foam device as a sphere which is then pulled out with the attached string, providing brushing/cytology samples of the proximal stomach and esophagus. |
| BG001 | Phase 1:Sponge on a String 25 mm 20 Pores/Inch | In phase 1 of the study, subjects will be assigned to swallow a capsule sponge device 25 mm 20 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy Capsule Sponge Device 25 mm 20 pores/inch: Polyurethane foam sponge compressed in a vegetable material derived capsule, attached to a string. The capsule is swallowed by the patient. The shell of the capsule dissolves in the gastric fluid releasing the foam device as a sphere which is then pulled out with the attached string, providing brushing/cytology samples of the proximal stomach and esophagus. |
| BG002 | Phase 2: Cases - Barrett's Esophagus | In phase 2 of the study, additional subjects will be assigned to swallow a capsule sponge device 25 mm 10 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy Capsule Sponge Device 25 mm 10 pores/inch: Polyurethane foam sponge compressed in a vegetable material derived capsule, attached to a string. The capsule is swallowed by the patient. The shell of the capsule dissolves in the gastric fluid releasing the foam device as a sphere which is then pulled out with the attached string, providing brushing/cytology samples of the proximal stomach and esophagus. |
| BG003 | Phase 2: Controls - No Barrett's Esophagus | In phase 2 of the study, additional subjects will be assigned to swallow a capsule sponge device 25 mm 10 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy Capsule Sponge Device 25 mm 10 pores/inch: Polyurethane foam sponge compressed in a vegetable material derived capsule, attached to a string. The capsule is swallowed by the patient. The shell of the capsule dissolves in the gastric fluid releasing the foam device as a sphere which is then pulled out with the attached string, providing brushing/cytology samples of the proximal stomach and esophagus. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| ||||||||||
| Region of Enrollment | Number | 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 | Number of Subjects That Would Have This Procedure Again | Number of subjects that answered yes to the self-reported question "Would you choose to have this procedure again to screen for Barrett's esophagus?" | Data collected and analyzed for only Phase 1: Sponge on a String 25 mm 10 pores/inch group and Phase 1:Sponge on a String 25 mm 20 pores/inch as this outcome is specific for phase 1 of the study only | Posted | Count of Participants | Participants | Within 24 hours of the capsule sponge administration |
|
|
| |||||||||||||||||||||||||||||
| Primary | Tolerability of Swallowing the Sponge Device | Measured using a self-reported 5-item tolerability assessment rating discomfort during the procedure on a Likert scale of 0-10; 10 representing the "worst experience" and 0 the "best experience." This scale allows a comprehensive and individual assessment of the degree of pain, choking, gagging, anxiety and overall experienced during the procedure. | Data collected and analyzed for only Phase 1: Sponge on a String 25 mm 10 pores/inch group and Phase 1:Sponge on a String 25 mm 20 pores/inch as this outcome is specific for phase 1 of the study only | Posted | Median | Inter-Quartile Range | units on a scale | Within 24 hours of the capsule sponge administration |
| ||||||||||||||||||||||||||||||
| Primary | Mucosal Irritation | Measured using a mucosal injury score (ranging from 1=no trauma to 5=severe) was scored from video recordings of the subsequent endoscopy conducted | Data collected and analyzed for only Phase 1: Sponge on a String 25 mm 10 pores/inch group and Phase 1:Sponge on a String 25 mm 20 pores/inch as this outcome is specific for phase 1 of the study only | Posted | Median | Full Range | score on a scale | Within 24 hours of the capsule sponge administration |
| ||||||||||||||||||||||||||||||
| Primary | DNA Yield | Total amount of DNA obtained from esophageal cytology specimens collected by the capsule sponge devices. | Data collected and analyzed for only Phase 1: Sponge on a String 25 mm 10 pores/inch group and Phase 1:Sponge on a String 25 mm 20 pores/inch as this outcome is specific for phase 1 of the study only | Posted | Median | Inter-Quartile Range | μg | Within 24 hours of the capsule sponge administration |
| ||||||||||||||||||||||||||||||
| Secondary | Sensitivity of Barrett's Dysplasia Detection | The sensitivity methylated DNA markers detected by the capsule sponge, in making a diagnosis of BE related dysplasia will be assessed using endoscopic surveillance biopsy histology as a gold standard. | Phase 2:Controls - No Barrett's Esophagus were not analyzed for this outcome due to the outcome being specific to BE related dysplasia | Posted | Number | 95% Confidence Interval | percentage of sensitivity | Within 24 hours of the capsule sponge administration |
| ||||||||||||||||||||||||||||||
| Secondary | Specificity of Barrett's Dysplasia Detection | The specificity of methylated DNA markers detected by the capsule sponge, in identifying subjects without a diagnosis of BE related dysplasia will be assessed using endoscopic surveillance biopsy histology as a gold standard. | Phase 2: Cases-Barrett's Esophagus were not analyzed for this outcome due to the outcome being specific to correctly identifying subjects without BE related dysplasia | Posted | Number | 95% Confidence Interval | percentage of specificity | Within 24 hours of the capsule sponge administration |
|
Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1: Sponge on a String 25 mm 10 Pores/Inch | In phase 1 of the study, subjects will be assigned to swallow a capsule sponge device 25 mm 10 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy Capsule Sponge Device 25 mm 10 pores/inch: Polyurethane foam sponge compressed in a vegetable material derived capsule, attached to a string. The capsule is swallowed by the patient. The shell of the capsule dissolves in the gastric fluid releasing the foam device as a sphere which is then pulled out with the attached string, providing brushing/cytology samples of the proximal stomach and esophagus. | 0 | 19 | 0 | 19 | 5 | 19 |
| EG001 | Phase 1:Sponge on a String 25 mm 20 Pores/Inch | In phase 1 of the study, subjects will be assigned to swallow a capsule sponge device 25 mm 20 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy Capsule Sponge Device 25 mm 20 pores/inch: Polyurethane foam sponge compressed in a vegetable material derived capsule, attached to a string. The capsule is swallowed by the patient. The shell of the capsule dissolves in the gastric fluid releasing the foam device as a sphere which is then pulled out with the attached string, providing brushing/cytology samples of the proximal stomach and esophagus. | 0 | 22 | 0 | 22 | 8 | 22 |
| EG002 | Phase 2: Cases - Barrett's Esophagus | In phase 2 of the study, additional subjects will be assigned to swallow a capsule sponge device 25 mm 10 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy Capsule Sponge Device 25 mm 10 pores/inch: Polyurethane foam sponge compressed in a vegetable material derived capsule, attached to a string. The capsule is swallowed by the patient. The shell of the capsule dissolves in the gastric fluid releasing the foam device as a sphere which is then pulled out with the attached string, providing brushing/cytology samples of the proximal stomach and esophagus. | 0 | 112 | 5 | 112 | 31 | 112 |
| EG003 | Phase 2: Controls - No Barrett's Esophagus | In phase 2 of the study, additional subjects will be assigned to swallow a capsule sponge device 25 mm 10 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy Capsule Sponge Device 25 mm 10 pores/inch: Polyurethane foam sponge compressed in a vegetable material derived capsule, attached to a string. The capsule is swallowed by the patient. The shell of the capsule dissolves in the gastric fluid releasing the foam device as a sphere which is then pulled out with the attached string, providing brushing/cytology samples of the proximal stomach and esophagus. | 0 | 89 | 1 | 89 | 30 | 89 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization after EGD/ESD procedure | Surgical and medical procedures | Systematic Assessment | Unrelated to study |
| |
| Hospitalization: Distal esophageal perforation after endoscopic mucosal perforation | Surgical and medical procedures | Systematic Assessment | Unrelated to study |
| |
| ER Presentation: Compliant of sore throat 3 days after procedure | Surgical and medical procedures | Systematic Assessment | Unrelated to study |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Throat Irritation | General disorders | Systematic Assessment |
| ||
| Pain under rib cage | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Difficulty swallowing | Gastrointestinal disorders | Systematic Assessment |
| ||
| Clearing throat | Gastrointestinal disorders | Systematic Assessment |
| ||
| Bruise on lower lip | General disorders | Systematic Assessment |
| ||
| Heartburn | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dark lesions distal esophagus | Gastrointestinal disorders | Systematic Assessment |
| ||
| Mild rectal bleeding | Gastrointestinal disorders | Systematic Assessment |
| ||
| Taste of blood in mouth | General disorders | Systematic Assessment |
| ||
| Stomach pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Blood in stool | Gastrointestinal disorders | Systematic Assessment |
| ||
| Discomfort behind breast bone | General disorders | Systematic Assessment |
| ||
| Esophageal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Mild pain following procedure | General disorders | Systematic Assessment |
| ||
| Slow transit time of solid food | Gastrointestinal disorders | Systematic Assessment |
| ||
| General discomfort | General disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Prasad G. Iyer | Mayo Clinic | 507-293-7911 | iyer.Prasad@mayo.edu |
| Jul 27, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| D005764 | Gastroesophageal Reflux |
| C562730 | Adenocarcinoma Of Esophagus |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D013048 | Specimen Handling |
| D004724 | Endoscopy |
| ID | Term |
|---|---|
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D019060 | Minimally Invasive Surgical Procedures |
Not provided
Not provided
|
|
|
|
In phase 1 of the study, subjects will be assigned to swallow a capsule sponge device 25 mm 20 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy
Capsule Sponge Device 25 mm 20 pores/inch: Polyurethane foam sponge compressed in a vegetable material derived capsule, attached to a string. The capsule is swallowed by the patient. The shell of the capsule dissolves in the gastric fluid releasing the foam device as a sphere which is then pulled out with the attached string, providing brushing/cytology samples of the proximal stomach and esophagus.
|
|
|
|
|
|
|
|
|
|