Crohn's Disease of Large IntestineNCT04964297
Evaluation of Ability to Detect Bowel Gas During Laparoscopic Right Colectomy With Intracorporeal Anastomosis
A study testing Obtaining bowel gas samples in people with Crohn's Disease of Large Intestine and Malignant Neoplasm of Colon, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease of Large Intestine, Malignant Neoplasm of Colon
- What is being tested?
- Obtaining bowel gas samples
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2021to 16 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥ 18 years of age.
- Documentation of a required elective right laparoscopic hemicolectomy with intracorporeal anastomosis
- Subject signed inform consent
Who cannot join
- Less than 18 years old
- Pregnant or breastfeeding patients
- Patients undergoing emergency laparotomy for perforated right colon or trauma
- Patients with Intraabdominal abscess, peritonitis, or enteric fistula
- Patients who are on peritoneal dialysis
- Subjects do not speak English
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The goal of this study 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. During laparoscopic surgery, CO2 is inserted into the abdominal cavity in order to perform the operation. This is a dynamic process as insufflation is constant during the entire procedure to maintain constant pressure and compensate for any small leaks due to the insertion and retrieval of instruments.
This study will determine the ability of a novel device to be attached to a standard trocar during the operation and periodically draw a small amount 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, first the investigators must ensure that it can accurately detect bowel gas in an insufflated abdomen.
The Investigational device, Perf-AlertTM, 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 ( Image1). It is used in conjunction with a single-use, disposable kit consisting of sterile tubing and filters used for sample collection and transport (Image 2). 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 the procedure, a one-way valve will be opened and the unit's pump turned on pulling small aliquots of gas from the abdominal cavity to the sensing unit. The system's architecture is configured such 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. No changes to the device are anticipated during the course of the study.
- Being tested
- Obtaining bowel gas samples
- Keywords
- Colon cancer, Crohn's disease, Perf-AlertTM device, Hydrogen gas(H2), gas Methane (CH4)
- Medical subject headings
- Crohn Disease, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obtaining bowel gas samplesDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Predetermined points measurement | Other | 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 Receives: Device: Obtaining bowel gas samples |
| Cohort 2: Continuous monitoring | Other | 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. Receives: Device: Obtaining bowel gas samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: during surgery(from start of laparoscopy to the end of surgical procedure)
Secondary outcomes (1)
Response Time of the Perf-AlertTM Device.
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
Measured: during surgery(from start of laparoscopy to the end of surgical procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start9 Aug 2021
- Primary completion15 Apr 2024
- Study completion16 Sep 2024
Why it stopped: Need for device upgrade.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Crohn's Disease of Large IntestineStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Prospective pilot, single-center, single-arm, open-label, phase 1 investigator-initiated study to determine device ability to detect bowel gas during laparoscopic right colectomy with intracorporeal anastomosis using Perf-AlertTM gas detection system on 20 subjects into 2 Cohorts. Cohort 1: 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: 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.
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Sentire Medical Systems
- Responsible party
- Sponsor
- Investigators
- Mehraneh Jafari, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04964297
- Sponsor's protocol ID
- 20-10022823
- Status last verified
- May 2025
- First submitted
- 7 Jul 2021
- Last updated
- 6 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ability to Detect Bowel Gas During Laparoscopic Right Colectomy With Intracorporeal Anastomosis
- ClinicalTrials.gov ID
- NCT04964297
- Acronym / sponsor ID
- 20-10022823
- Keywords
- Colon cancer, Crohn's disease, Perf-AlertTM device, Hydrogen gas(H2), gas Methane (CH4)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Need for device upgrade.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Sentire Medical Systems
- Study start
- 9 Aug 2021 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 16 Sep 2024 (actual)
- First posted
- 16 Jul 2021 (actual)
- Results
- Posted 6 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The goal of this study 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. During laparoscopic surgery, CO2 is inserted into the abdominal cavity in order to perform the operation. This is a dynamic process as insufflation is constant during the entire procedure to maintain constant pressure and compensate for any small leaks due to the insertion and retrieval of instruments.
This study will determine the ability of a novel device to be attached to a standard trocar during the operation and periodically draw a small amount 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, first the investigators must ensure that it can accurately detect bowel gas in an insufflated abdomen.
The Investigational device, Perf-AlertTM, 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 ( Image1). It is used in conjunction with a single-use, disposable kit consisting of sterile tubing and filters used for sample collection and transport (Image 2). 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 the procedure, a one-way valve will be opened and the unit's pump turned on pulling small aliquots of gas from the abdominal cavity to the sensing unit. The system's architecture is configured such 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. No changes to the device are anticipated during the course of the study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective pilot, single-center, single-arm, open-label, phase 1 investigator-initiated study to determine device ability to detect bowel gas during laparoscopic right colectomy with intracorporeal anastomosis using Perf-AlertTM gas detection system on 20 subjects into 2 Cohorts. Cohort 1: 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: 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.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Predetermined points measurement | Other | Device: Obtaining bowel gas samplesCohort 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 | Other | Device: Obtaining bowel gas samplesCohort 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female ≥ 18 years of age.
- Documentation of a required elective right laparoscopic hemicolectomy with intracorporeal anastomosis
- Subject signed inform consent
Key exclusion criteria (6 listed)
- Less than 18 years old
- Pregnant or breastfeeding patients
- Patients undergoing emergency laparotomy for perforated right colon or trauma
- Patients with Intraabdominal abscess, peritonitis, or enteric fistula
- Patients who are on peritoneal dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Obtaining bowel gas samplesThe 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. | Device | Cohort 1: Predetermined points measurement, Cohort 2: Continuous monitoring |
Primary outcome
Methane (CH4) Gas
Time frame: during surgery(from start of laparoscopy to the end of surgical procedure)
Methane (CH4) gas measured in ppm or mg/L (parts per million or milligrams per liter (mg/L) at 8-time points
Hydrogen (H2) Gas
Time frame: during surgery(from start of laparoscopy to the end of surgical procedure)
Hydrogen (H2) gas measured in ppm or mg/L (parts per million or milligrams per liter (mg/L) at 8-time points
1 secondary outcome
Response Time of the Perf-AlertTM Device.
Time frame: during surgery(from start of laparoscopy to the end of surgical procedure)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehraneh Jafari, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Obtaining bowel gas samples in people with Crohn's Disease of Large Intestine and Malignant Neoplasm of Colon, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Methane (CH4) Gas (time frame: during surgery(from start of laparoscopy to the end of surgical procedure)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.