Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2007-07-31
2009-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
NONE
Study Groups
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4
10 patients with history of previous abdominal surgeries, no veress needle pre-insufflation (insufflating the abdominal cavity through the endoscope, transgastrically)
Transgastric access to the abdomen
Upper endoscopy, gastrotomy created with a needle knife followed by lower endoscopy.
5
10 patients, all with no previous mid to upper abdominal surgeries, no Veress needle pre-insufflation (insufflating the abdominal cavity through the endoscope, transgastrically)
Transgastric access to the abdomen
Upper endoscopy, gastrotomy created with a needle knife followed by lower endoscopy.
6
10 patients, all with previous mid-to-upper abdominal surgeries, no Veress needle pre-insufflation, endoscopic take-down of intra-abdominal adhesions (if identified)
Transgastric access to the abdomen
Upper endoscopy, gastrotomy created with a needle knife followed by lower endoscopy.
1
10 patients with no previous abdominal surgeries, pre-insufflation of the abdomen using a veress needle (standard procedure for insufflating the abdomen for laparoscopic surgery)
Transgastric access to the abdomen
Upper endoscopy, gastrotomy created with a needle knife followed by lower endoscopy.
2
10 patients with history of previous abdominal surgeries, pre-insufflation of the abdomen using veress needle (standard procedure for insufflating the abdomen for laparoscopic surgery)
Transgastric access to the abdomen
Upper endoscopy, gastrotomy created with a needle knife followed by lower endoscopy.
3
10 patients with no previous history of abdominal surgeries, no veress needle pre-insufflation (insufflating the abdominal cavity through the endoscope, transgastrically)
Transgastric access to the abdomen
Upper endoscopy, gastrotomy created with a needle knife followed by lower endoscopy.
Interventions
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Transgastric access to the abdomen
Upper endoscopy, gastrotomy created with a needle knife followed by lower endoscopy.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* History of previous gastric surgery
* Contraindication to upper endoscopy
18 Years
65 Years
ALL
No
Sponsors
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Stryker SA
INDUSTRY
Natural Orifice Surgery Consortium for Assessment and Research
OTHER
Jeffrey Hazey
OTHER
Responsible Party
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Jeffrey Hazey
Associate Professor
Principal Investigators
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Jeffrey W Hazey, MD
Role: PRINCIPAL_INVESTIGATOR
The Ohio State University Medical Center/Center for Minimally Invasive Surgery
Locations
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The Ohio State University Medical Center/Center for Minimally Invasive Surgery
Columbus, Ohio, United States
Countries
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Other Identifiers
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Project 60009927
Identifier Type: -
Identifier Source: secondary_id
Award GRT00006515
Identifier Type: -
Identifier Source: secondary_id
IRB 2007H0045
Identifier Type: -
Identifier Source: secondary_id
NOTES Trocar Study
Identifier Type: -
Identifier Source: org_study_id
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