An interventional study of Transgastric diagnostic peritoneoscopy with laparoscopic assistance in Abdominal Adhesions, sponsored by Ethicon Endo-Surgery. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-03-29.
Sponsored by Ethicon Endo-Surgery · Not applicable, Interventional, and Diagnostic
The study will document being able to successfully perform transgastric diagnostic peritoneoscopy (laparoscopic visualization) using a small collection of study surgical tools.
241 studies on the registry are indexed under Tissue Adhesions; 29 are open to participants now.
This study's enrollment of 7 is below the median of 60 across 184 interventional studies indexed under Tissue Adhesions.
Browse Tissue Adhesions studies →Ethicon Endo-Surgery is the lead sponsor of 47 studies on the registry; 1 is open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 7 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Men and women will be enrolled in this study who:
Exclusion Criteria:
Subjects will be excluded from the study for any of the following:
Multiple devices designed for trans-orifice use during surgical procedures; used for transvaginal cholecystectomy in this trial
Device: 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)
Completion of Diagnostic Peritineoscopy
Number of participants in which transgastric access was achieved using the EES NOTES GEN1 Toolbox Outcome description: Completion of diagnostic peritoneoscopy after transgastric access was completed using a flexible, steerable trocar. Because this was a feasibility trial, transgastric access was the primary outcome.
Time frame: Assessed intra-operatively as the time from first insertion of the flexible trocar into the oral cavity to final withdrawal of the flexible trocar
Study Initiation Date: 09 June 2009 (First Informed consent signed) Study Completion Date:03 May 2010 (Last subject last visit) Enrollment Location: The Ohio State University Medical Center
| Milestone | Natural Orifice Transgastric Diagnostic Peritineoscopy |
|---|---|
| Started | 10 |
| Completed | 8 |
| Not completed | 2 |
| Withdrew: Transgastric dp was not completed | 2 |
Number of participants in which transgastric access was achieved using the EES NOTES GEN1 Toolbox Outcome description: Completion of diagnostic peritoneoscopy after transgastric access was completed using a flexible, steerable trocar. Because this was a feasibility trial, transgastric access was the primary outcome.
| Participants | Natural Orifice Transgastric Diagnostic Peritineoscopy |
|---|---|
| Completion of Diagnostic Peritineoscopy | 8 |
Collected over Adverse events were collected from Study Initiation Date (first Informed Consent signed) 09 June 2009 until Study Completion Date (last participant's last visit) on 03 May 2010.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Natural Orifice Transgastric Diagnostic Peritineoscopy | — | 1/10 (10%) | 0/10 (0%) |
| Event | Natural Orifice Transgastric Diagnostic Peritineoscopy |
|---|---|
| ESOPHAGEAL INJURY/ OESOPHAGEAL INJURYSurgical and medical procedures | 1/10 |
| Age, Categorical(Participants) | Natural Orifice Transgastric Diagnostic Peritineoscopy |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 9 |
| >=65 years | 1 |
| Age Continuous(years) | Natural Orifice Transgastric Diagnostic Peritineoscopy |
|---|---|
| Mean | 54.2 ± 9.76 |
| Sex: Female, Male(Participants) | Natural Orifice Transgastric Diagnostic Peritineoscopy |
|---|---|
| Female | 9 |
| Male | 1 |
| Region of Enrollment(participants) | Natural Orifice Transgastric Diagnostic Peritineoscopy |
|---|---|
| United States | 10 |
This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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Ethicon Endo-Surgery