Natural Orifice Transgastric Endoscopic (NOTES) Transgastric Diagnostic Peritoneoscopy With Laparoscopic Assistance

NCT ID: NCT00962650

Last Updated: 2012-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2010-10-31

Brief Summary

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

Conditions

Abdominal Adhesions

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

NOTES Toolbox

Multiple devices designed for trans-orifice use during surgical procedures; used for transvaginal cholecystectomy in this trial

Group Type: EXPERIMENTAL

Transgastric diagnostic peritoneoscopy with laparoscopic assistance

Intervention Type: DEVICE

Device: Natural Orifice Transgastric Endoscopic (NOTES GEN 1 Toolbox): Articulating Hook Knife(IN2505), Articulating Snare (IN2503), Articulating Needle Knife(IN2504), Articulating Graspers(IN2501 or IN2506), Articulating Biopsy Forceps(IN2502), Steerable Flexible Trocar (IN0501) with Rotary Access Needle (IN0502), Flexible Bipolar Hemostasis Forceps (IN0301), and/or Flexible Maryland Dissector(IN1601)

Interventions

Transgastric diagnostic peritoneoscopy with laparoscopic assistance

Device: Natural Orifice Transgastric Endoscopic (NOTES GEN 1 Toolbox): Articulating Hook Knife(IN2505), Articulating Snare (IN2503), Articulating Needle Knife(IN2504), Articulating Graspers(IN2501 or IN2506), Articulating Biopsy Forceps(IN2502), Steerable Flexible Trocar (IN0501) with Rotary Access Needle (IN0502), Flexible Bipolar Hemostasis Forceps (IN0301), and/or Flexible Maryland Dissector(IN1601)

Intervention Type: DEVICE

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ethicon Endo-Surgery

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey W Hazey, MD, FACS

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University Medical Center

Columbus, Ohio, United States

Countries

United States

Other Identifiers

CI-08-0007

Identifier Type: -

Identifier Source: org_study_id