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
The objectives of this clinical trial are to assess in a pilot setting the overall performance and safety of the Endo GIA™ Stapler with Endo GIA™ SULU with Tri-Staple™ Technology when used in a gastric bypass procedure.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tri Staple | Experimental | This is a single arm study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tri Staple Technology stapler | Device | This is a single arm study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients With an Uneventful Creation of a Functional Staple Line | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Intra-operative Bleeding Requiring Intervention | Day 0 and 1 month | |
| Length of Hospital Stay | Date of discharge which averages 3 days | |
| Incidence of Serosal Tearing |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Samer G Mattar, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clarian Bariatric Center/Indiana University | Indianapolis | Indiana | 46202 | United States |
thirty patients consented, 1 was excluded by physician for elevated liver function test; 1 was not considered enrolled as subject did not receive study device in error, leaving 28 enrolled subjects.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Tri Staple | This is a single arm study. Tri Staple Technology stapler : This is a single arm study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
30 patients consented; 1 patient was withdrawn by physician for elevated liver function test. Twenty-nine (29) patients had baseline characteristics but 1 did not receive study device in error leaving 28 patients enrolled.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tri Staple | This is a single arm study. Tri Staple Technology stapler : This is a single arm study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Proportion of Patients With an Uneventful Creation of a Functional Staple Line | Posted | Number | participants | Day 0 |
|
|
30 days post surgery
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 | Tri Staple | This is a single arm study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stricture | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bloating | Gastrointestinal disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Noreen Fahey | Covidien | 203-821-4716 | noreen.fahey@covidien.com |
Not provided
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D006973 | Hypertension |
| D006949 | Hyperlipidemias |
| D003324 | Coronary Artery Disease |
| D005764 | Gastroesophageal Reflux |
| D010003 | Osteoarthritis |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 30 days post op |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Incidence of Intra-operative Bleeding Requiring Intervention | Posted | Number | participants | Day 0 and 1 month |
|
|
|
| Secondary | Length of Hospital Stay | Posted | Mean | Standard Deviation | days | Date of discharge which averages 3 days |
|
|
|
| Secondary | Incidence of Serosal Tearing | Posted | Number | participants | 30 days post op |
|
|
|
| 2 |
| 28 |
| 24 |
| 28 |
| GI Bleed | Gastrointestinal disorders | Systematic Assessment |
|
| Blood Loss | Surgical and medical procedures | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Edema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Hypertension | Cardiac disorders | Non-systematic Assessment |
|
| Infection | Infections and infestations | Non-systematic Assessment |
|
| Nausea | General disorders | Non-systematic Assessment |
|
| Pain | Surgical and medical procedures | Non-systematic Assessment |
|
| Ulcer | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vomitting | General disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
Not provided
Not provided
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D044882 | Glucose Metabolism Disorders |
| D004700 | Endocrine System Diseases |