Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
For removal of large flat lesions of the gastro-intestinal tract injection of a solution under the lesion creates a "safety" cushion and protects from damage to the gastrointestinal tract wall. Various solutions are currently used, but some of them are easy to inject but quickly dissipate (normal saline),other solutions are more longer lasting (hydroxypropyl methylcellulose, hyaluronic acid, etc) but are very difficult to inject and can be expensive and not always available. The investigators performed previously animal experiments which demonstrated that blood is easy to inject and creates a protective cushion which lasts longer than other fluids which are currently used for protective cushion creation.
For removal of large flat lesions of the gastro-intestinal tract injection of a solution under the lesion creates a "safety" cushion and protects from damage to the gastrointestinal tract wall. Various solutions are currently used, but some of them are easy to inject but quickly dissipate (normal saline),other solutions are more longer lasting (hydroxypropyl methylcellulose, hyaluronic acid, etc) but are very difficult to inject and can be expensive and not always available. The investigators decided to use blood drawn from the patient for injection under the lesion. The investigators performed previously animal experiments which demonstrated that blood is easy to inject and creates a protective cushion which lasts longer than other fluids which are currently used for protective cushion creation. Blood can also have local hemostatic action preventing from bleeding during polypectomy.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Normal saline arm | Active Comparator | Polypectomy with normal saline injected for submucosal cushion creation |
|
| 2 HPMC arm | Active Comparator | Polypectomy after injection of hydroxypropyl methylcellulose (HPMC) to create submucosal cushion |
|
| 3 Blood arm | Experimental | Polypectomy after injection of autologous blood |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous blood injection | Drug | Autologous blood will be drawn from the patient and then reinjected under the lesion to create a safety cushion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of the Submucosal Cushion | Immediately after the procedure, Up to 5 minutes |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sergey V. Kantsevoy, M.D., Ph.D. | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17163324 | Background | Giday SA, Magno P, Buscaglia JM, Canto MI, Ko CW, Shin EJ, Xia L, Wroblewski LM, Clarke JO, Kalloo AN, Jagannath SB, Kantsevoy SV. Is blood the ideal submucosal cushioning agent? A comparative study in a porcine model. Endoscopy. 2006 Dec;38(12):1230-4. doi: 10.1055/s-2006-944971. |
Not provided
Not provided
Not provided
No data on how participants were randomized, and no further baseline data (other than categorical age and sex) are available for this record. The PI has left the institution and has been contacted. Per the PI the data are no longer available and the study has not been published.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Polypectomy with normal saline injected for submucosal cushion creation Normal saline: Normal saline will be injected under the lesion to create submucosal cushion OR Polypectomy after injection of hydroxypropyl methylcellulose (HPMC) to create submucosal cushion HPMC: Hydroxypropyl methylcellulose (HPMC) will be injected under the lesion to create submucosal cushion OR Polypectomy after injection of autologous blood Autologous blood injection: Autologous blood will be drawn from the patient and then reinjected under the lesion to create a safety cushion |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
No data on how participants were randomized, and no further baseline data (other than categorical age and sex) are available for this record. The PI has left the institution and has been contacted. Per the PI the data are no longer available and the study has not been published.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Polypectomy with normal saline injected for submucosal cushion creation Normal saline: Normal saline will be injected under the lesion to create submucosal cushion OR Polypectomy after injection of hydroxypropyl methylcellulose (HPMC) to create submucosal cushion HPMC: Hydroxypropyl methylcellulose (HPMC) will be injected under the lesion to create submucosal cushion OR Polypectomy after injection of autologous blood Autologous blood injection: Autologous blood will be drawn from the patient and then reinjected under the lesion to create a safety cushion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Duration of the Submucosal Cushion | No data is available for this record. The PI has left the institution and has been contacted. Per the PI the data is no longer available and the study has not been published. | Posted | Immediately after the procedure, Up to 5 minutes |
|
Not provided
There is no adverse event data available for this record. The PI has left the institution and has been contacted. Per the PI the data is no longer available and the study has not been published.
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 | All Participants | Polypectomy with normal saline injected for submucosal cushion creation Normal saline: Normal saline will be injected under the lesion to create submucosal cushion OR Polypectomy after injection of hydroxypropyl methylcellulose (HPMC) to create submucosal cushion HPMC: Hydroxypropyl methylcellulose (HPMC) will be injected under the lesion to create submucosal cushion OR Polypectomy after injection of autologous blood Autologous blood injection: Autologous blood will be drawn from the patient and then reinjected under the lesion to create a safety cushion |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Johns Hopkins ClinicalTrials.gov Program | Johns Hopkins University | 410-550-6484 | registerclinicaltrials@jhmi.edu |
Not provided
| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Normal saline | Drug | Normal saline will be injected under the lesion to create submucosal cushion |
|
| HPMC | Drug | Hydroxypropyl methylcellulose (HPMC) will be injected under the lesion to create submucosal cushion |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | 3 Blood Arm | Polypectomy after injection of autologous blood Autologous blood injection: Autologous blood will be drawn from the patient and then reinjected under the lesion to create a safety cushion |
|
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
Not provided
Not provided
Not provided