NCT04964297|TerminatedResultsFDA Device
Study Stopped
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Sponsor study identifier
interventional
3
1 country
1
Study Start
August 9, 2021
Actual (reported)Primary Completion
April 15, 2024
Actual (reported)Study Completion
September 16, 2024
Actual (reported)Undetected bowel perforation is a rare but dangerous complication of laparoscopic surgery. If the injury is not detected and treated at the time of the surgical procedure, the patient can suffer severe complications, including septic shock and eventually death. The investigator's goal is to test a novel device that can detect bowel gas leakage from perforation and alert the surgeon during the operation by evaluating the gases present in the insufflated abdomen during surgery. This study will determine the ability of the device to be attached to a standard trocar during the operation and periodically draw small samples or aliquots of gas from the abdomen to evaluate the gas and accurately detect gaseous content from the bowel. Before the device can be used to detect bowel perforations, the investigators must first ensure that it can accurately detect bowel gas in an insufflated abdomen.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 16, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 7, 2021
Actual (reported)July 16, 2021
Actual (reported)August 9, 2021
Actual (reported)April 15, 2024
Actual (reported)September 16, 2024
Actual (reported)June 6, 2025
Actual (reported)Methane (CH4) Gas
Methane (CH4) gas measured in ppm or mg/L (parts per million or milligrams per liter (mg/L) at 8-time points
during surgery(from start of laparoscopy to the end of surgical procedure)
Hydrogen (H2) Gas
Hydrogen (H2) gas measured in ppm or mg/L (parts per million or milligrams per liter (mg/L) at 8-time points
during surgery(from start of laparoscopy to the end of surgical procedure)
Response Time of the Perf-AlertTM Device.
during surgery(from start of laparoscopy to the end of surgical procedure)
Cohort 1: Predetermined points measurement: 10 subjects with measurement of bowel gas at 8 predetermined time points during right laparoscopic colectomy as follow: 1. Initiation of surgery/laparoscopy start Insufflation 2. Abdominal exploration 3. Completion of colon mobilization 4. Colon transection 5. At Colotomy 6. At Enterotomy 7. Anastomosis completion 8. End of surgery- after re-insufflation before closure
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.
The Perf-AlertTM prototype consists of a 15" x 13" x 7" unit containing gas sensors and valves, a small box containing a one-way, ultra-low pressure pump, user controls (buttons), and software algorithms, which control the operation of the device. It is used in conjunction with a single-use, disposable kit of sterile tubing and filters used for sample collection. The sensing unit will be connected via a sterile tube/filter set to any trocar port in use during the procedure. At specific time points during surgery, a one-way valve will be opened, and the unit's pump turned on and withdrawing a small amount of gas from the abdominal cavity. The system is configured that sample collection, transport, analysis, and feedback occur in a single step such that sample collection and sensor feedback occur in real-time. A standard laptop running an analytical software program is connected to the unit to record and log sensor readings.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Weill Cornell Medicine
New York, New York, 10065, United States
This study was terminated leading to small numbers of subjects enrolled and analyzed.
Mehraneh Jafari, MD
Weill Medical College of Cornell University
3 participants (actual enrollment reported by the registry).
First Submitted
July 7, 2021
Contact the study team to confirm eligibility.
First Posted
July 16, 2021
Study Start
August 9, 2021
Actual (reported)Primary Completion
April 15, 2024
Actual (reported)Study Completion
September 16, 2024
Actual (reported)Last Updated
June 6, 2025
Results First Posted
June 6, 2025
Record last verified: 2025-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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