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Bowel Gas Detection Device for Laparoscopic Colectomy Procedures

N/A

Recruiting

Led By Alessio Pigazzi, MD,PhD

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Documentation of a required elective right laparoscopic hemicolectomy with intracorporeal anastomosis

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during surgery(from start of laparoscopy to the end of surgical procedure)

Awards & highlights

Study Summary

This trialwill evaluate a device that can detect bowel gas leakage during laparoscopic surgery, which can prevent severe complications and death caused by undetected perforation.

Who is the study for?

This trial is for adults over 18 who need elective laparoscopic right colectomy with intracorporeal anastomosis and can give informed consent. It's not for non-English speakers, emergency cases, peritoneal dialysis patients, those with abdominal infections or fistulas, or pregnant/breastfeeding individuals.Check my eligibility

What is being tested?

The study tests a new device designed to detect bowel gas from perforations during laparoscopic surgery by sampling gases in the abdomen. The goal is to ensure it accurately identifies bowel gas without interrupting the procedure.See study design

What are the potential side effects?

Since this trial involves testing a detection device rather than medication, traditional side effects are not expected. However, there may be minimal risks associated with attaching the device to surgical equipment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for a specific surgery on the right side of my colon.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during surgery(from start of laparoscopy to the end of surgical procedure)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during surgery(from start of laparoscopy to the end of surgical procedure)

This trial's timeline: 3 weeks for screening, Varies for treatment, and during surgery(from start of laparoscopy to the end of surgical procedure) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Hydrogen (H2) gas

Methane (CH4) gas

Secondary outcome measures

Response time of the Perf-AlertTM device.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort 2: Continuous monitoringExperimental Treatment1 Intervention

Cohort 2: Continuous monitoring: 10 subjects with continuous monitoring of bowel gases through the surgery. The level of H2 and CH4 gases will be noted at the 8 predetermined time points during the continuous monitoring as well.

Group II: Cohort 1: Predetermined points measurementExperimental Treatment1 Intervention

Cohort 1: Predetermined points measurement: 10 subjects with measurement of bowel gas at 8 predetermined time points during right laparoscopic colectomy as follow: Initiation of surgery/laparoscopy start Insufflation Abdominal exploration Completion of colon mobilization Colon transection At Colotomy At Enterotomy Anastomosis completion End of surgery- after re-insufflation before closure

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor

1,055 Previous Clinical Trials

1,316,275 Total Patients Enrolled

Sentire Medical SystemsUNKNOWN

Alessio Pigazzi, MD,PhDPrincipal InvestigatorWeill Medical College of Cornell University

1 Previous Clinical Trials

12 Total Patients Enrolled

Media Library

Cohort 1: Predetermined points measurement Clinical Trial Eligibility Overview. Trial Name: NCT04964297 — N/A

Colon Cancer Research Study Groups: Cohort 1: Predetermined points measurement, Cohort 2: Continuous monitoring

Colon Cancer Clinical Trial 2023: Cohort 1: Predetermined points measurement Highlights & Side Effects. Trial Name: NCT04964297 — N/A

Cohort 1: Predetermined points measurement 2023 Treatment Timeline for Medical Study. Trial Name: NCT04964297 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this trial available to the public right now?

"Affirmative, the information on clinicaltrials.gov signals that this research trial is presently recruiting participants. The investigation was first advertised on August 9th 2021 and recently updated December 5th 2022. This inquiry is searching for 20 applicants from a single location."

Answered by AI

How many patients have been recruited to participate in this trial?

"Indeed, clinicaltrials.gov indicates that recruitment for this medical trial is in progress. Initially posted on the 9th of August 2021 and most recently revised on December 5th 2022, the study requires 20 participants to be sourced from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of Ability to Detect Bowel Gas During Laparoscopic Right Colectomy With Intracorporeal Anastomosis

2021. "Evaluation of Ability to Detect Bowel Gas During Laparoscopic Right Colectomy With Intracorporeal Anastomosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04964297.

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