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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NOT_YET_RECRUITING
NA
74 participants
INTERVENTIONAL
2026-01-10
2027-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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AirSeal® Insufflation System (AIS)
Use of CONMED AirSeal® during Laparoscopic Sleeve Gastrectomy.
AirSeal® Insufflation System (AIS)
insufflation device used during laparoscopic sleeve gastrectomy,
Lexicon Insufflator
Use of Lexicon Insufflators during Laparoscopic Sleeve Gastrectomy.
Lexicon AP 50/30 Insufflator
insufflation device used during laparoscopic sleeve gastrectomy,
Interventions
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AirSeal® Insufflation System (AIS)
insufflation device used during laparoscopic sleeve gastrectomy,
Lexicon AP 50/30 Insufflator
insufflation device used during laparoscopic sleeve gastrectomy,
Eligibility Criteria
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Inclusion Criteria
* . Subject (or appropriate legal representatives) can provide written informed consent to participate in the study
* Male or Female aged 22 years to 65 years
* Have no significant psychopathology that could limit the subject's ability to understand the procedure, comply with medical, surgical, and/or behavioral recommendations and office visits
* Agree to refrain from any type of elective procedures that would affect body weight such as abdominal lipoplasty or liposuction, mammoplasty, or removal of excess skin for the duration of the trial.
* Are graded as American Society of Anesthesiologists (ASA) Class I, II, or III.
Exclusion Criteria
* Subject requiring any surgical procedure in addition to Sleeve Gastrectomy
* Previous malabsorptive or restrictive procedures performed for the treatment of obesity
* Inability to provide informed consent
* Unable or unwilling to attend follow-up visits and examinations
* Uncontrolled hypertension (≥ Systolic: 180 mmHg or Diastolic: ≥ 120 mmHg) and/or diabetes mellitus (Fasting blood sugar level: \>200 mg/dL)
* Subject falls into American Society of Anesthesiologists (ASA) Class ≥ IV
* History of chronic alcohol or drug abuse within 2 years of the screening visit
* Chronic renal failure or on dialysis
* Significant complicating medical history or immunocompromise
* Subject undergoing surgery for malignant disease
* History or presence of pre-existing autoimmune connective tissue disease, e.g., systemic lupus erythematosus or scleroderma
* Immunocompromised, such as that resulting from chronic oral steroid use, chemotherapeutic agents, or immune deficiency disorders
* Any medical condition which precludes compliance with the study
* Subject with any other clinically significant unstable medical disorder, life threatening disease, or conditions that, in the opinion of the investigator, may jeopardize the subject's well-being and/or the soundness of this clinical study or which would contra-indicate a surgical procedure
* Previous or current history of being on regular analgesia / pain killers
* Advanced refusal of blood transfusion, (if necessary)
* If female subject pregnant, planning to become pregnant within 3 months (up to 92 days of procedure), or lactating
22 Years
65 Years
ALL
No
Sponsors
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SurgiQuest, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Nikhilesh Sekhar, MD FACS FASMBS
Role: PRINCIPAL_INVESTIGATOR
Bariatric and Specialty Surgery Center of Stamford
Locations
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Bariatric and Specialty Surgery Center of Stamford
Stamford, Connecticut, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DD1250901
Identifier Type: -
Identifier Source: org_study_id
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