Trial Outcomes & Findings for Evaluation of Ability to Detect Bowel Gas During Laparoscopic Right Colectomy With Intracorporeal Anastomosis (NCT NCT04964297)
NCT ID: NCT04964297
Last Updated: 2025-06-06
Results Overview
Methane (CH4) gas measured in ppm or mg/L (parts per million or milligrams per liter (mg/L) at 8-time points
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
3 participants
Primary outcome timeframe
during surgery(from start of laparoscopy to the end of surgical procedure)
Results posted on
2025-06-06
Participant Flow
Participant milestones
| Measure |
Cohort 1: Predetermined Points Measurement
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
Obtaining bowel gas samples: 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.
|
Cohort 2: Continuous Monitoring
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.
Obtaining bowel gas samples: 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.
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|---|---|---|
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Overall Study
STARTED
|
3
|
0
|
|
Overall Study
COMPLETED
|
3
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Ability to Detect Bowel Gas During Laparoscopic Right Colectomy With Intracorporeal Anastomosis
Baseline characteristics by cohort
| Measure |
Cohort 1: Predetermined Points Measurement
n=3 Participants
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
Obtaining bowel gas samples: 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.
|
Cohort 2: Continuous Monitoring
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.
Obtaining bowel gas samples: 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.
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
—
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
68.3 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
—
|
68.3 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
—
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
—
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
—
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
—
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: during surgery(from start of laparoscopy to the end of surgical procedure)Population: Zero participants were enrolled in Cohort 2.
Methane (CH4) gas measured in ppm or mg/L (parts per million or milligrams per liter (mg/L) at 8-time points
Outcome measures
| Measure |
Cohort 1: Predetermined Points Measurement
n=3 Participants
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
Obtaining bowel gas samples: 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.
|
Cohort 2: Continuous Monitoring
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.
Obtaining bowel gas samples: 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.
|
|---|---|---|
|
Methane (CH4) Gas
|
2.62 ppm
Standard Deviation 0.27
|
—
|
PRIMARY outcome
Timeframe: during surgery(from start of laparoscopy to the end of surgical procedure)Population: Zero participants were enrolled in Cohort 2.
Hydrogen (H2) gas measured in ppm or mg/L (parts per million or milligrams per liter (mg/L) at 8-time points
Outcome measures
| Measure |
Cohort 1: Predetermined Points Measurement
n=3 Participants
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
Obtaining bowel gas samples: 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.
|
Cohort 2: Continuous Monitoring
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.
Obtaining bowel gas samples: 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.
|
|---|---|---|
|
Hydrogen (H2) Gas
|
20.69 ppm
Standard Deviation 30.53
|
—
|
SECONDARY outcome
Timeframe: during surgery(from start of laparoscopy to the end of surgical procedure)Population: Zero participants were enrolled in Cohort 2.
The response time of the Perf-AlertTM device measured in seconds from obtaining the sample (from opening the valve to obtain sample) to first detecting a gas presence at the device electronic sensors
Outcome measures
| Measure |
Cohort 1: Predetermined Points Measurement
n=3 Participants
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
Obtaining bowel gas samples: 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.
|
Cohort 2: Continuous Monitoring
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.
Obtaining bowel gas samples: 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.
|
|---|---|---|
|
Response Time of the Perf-AlertTM Device.
|
12 seconds
Standard Deviation 20.78
|
—
|
Adverse Events
Cohort 1: Predetermined Points Measurement
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 2: Continuous Monitoring
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place