Clinical trial NCT00962650: Natural Orifice Transgastric Endoscopic (NOTES) Transgastric Diagnostic Peritoneoscopy With Laparoscopic Assistance
Official title: A Feasibility Trial to Evaluate Natural Orifice Transgastric Endoscopic Diagnostic Peritoneoscopy With Laparoscopic Assistance.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Adhesions
Keywords: abdominal adhesions
diagnostic peritoneoscopy
Natural Orifice Transluminal Endoscopic Surgery
NOTES
Lead sponsor: Ethicon Endo-Surgery
Sponsor class: INDUSTRY
First posted: 2009-08-20
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The study will document being able to successfully perform transgastric diagnostic peritoneoscopy (laparoscopic visualization) using a small collection of study surgical tools.


Eligibility criteria: Inclusion Criteria:

Men and women will be enrolled in this study who:

* Are willing to give consent and comply with evaluation and treatment schedule;
* At least 18 years of age;
* Are a candidate for surgical weight loss intervention (i.e. meet ASMBS and NIH criteria) for an RYGB procedure at the Investigational site;
* Have a history of open abdominal surgery or laparoscopic abdominal surgery;
* ASA Classification I, II, or III (Appendix II); and
* Have a negative serum pregnancy test (for women of childbearing potential).

Exclusion Criteria:

Subjects will be excluded from the study for any of the following:

* Use of immunosuppressive medications (within 6 months of surgery; single burst dosages and inhalable steroids are acceptable);
* Acute cholecystitis or acute pancreatitis;
* Evidence of abdominal abscess or mass;
* Diffuse peritonitis;
* Use of anticoagulants or anti-platelet agents (use of daily cardio protective doses of aspirin, up to 81 mg/day, is acceptable and shall not constitute an exclusion criterion) or the presence of coagulopathy;
* Clinical diagnosis of sepsis;
* Co-morbid condition(s) that could limit the subject's ability to participate in the study or to comply with follow-up requirements, or that could impact the scientific integrity of the trial;
* Planned concurrent surgical procedure other than RYGB or adhesiolysis;
* Prior or planned major surgical procedure within 30 days before or after study procedure;
* Participation in any other investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints;
* Previously enrolled in the current series of 4 trials investigating the EES NOTES GEN1 Toolbox; or
* Any condition which precludes compliance with the study (Investigator discretion).

Primary outcomes:
measure: Completion of Diagnostic Peritineoscopy
timeFrame: Assessed intra-operatively as the time from first insertion of the flexible trocar into the oral cavity to final withdrawal of the flexible trocar
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Jeffrey W Hazey, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References: