Colorectal SurgeryNCT06168669
A Safety and Effectiveness Prospective Blinded Clinical Study to Validate xBar System as Monitoring Tool for Anastomotic Leaks Detection
A study testing xBar system in people with Colorectal Surgery and Anastomotic Leak, run by Exero Medical Ltd. at 13 sites in 2 countries.
Trial summary
Purpose: To validate the safety and effectiveness of xBar monitoring tool for detection of post-operative anastomotic leaks in subjects undergoing rectal/sigmoid resections with anastomosis. The clinical team is blinded to the leak detection of the xBar system. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Colorectal Surgery, Anastomotic Leak
- What is being tested?
- xBar system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 11 Mar 2023to 29 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 22 years
- Indication for sigmoid or rectal resection surgery.
- Usage of drain during the surgery (to be confirmed during the surgery)
- Willing and able to comply with the study follow up.
- Able and agree to provide an informed consent.
Who cannot join
- Contraindication for surgery and/or general anesthesia.
- Pregnancy or lactation.
- Planned or unplanned fecal diversion during the surgery (to be confirmed during the surgery)
- Known electronic device implanted in the chest or the abdominal cavity (e.g., pacemaker, cardioverter/defibrillator).
- Major medical or psychiatric illness or condition, or other factors that may affect general health or ability to adhere to the follow-up schedule.
- Known allergic reactions to materials used in the components of the xBar system, i.e., silicone, rubber and stainless-steel.
- Participation in another interventional study during the xBar system usage.
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States10 sites
Henry Ford Health
Detroit, Michigan, 48202
HCA
Houston, Texas, 77030
Bryan Medical Center
Lincoln, Nebraska, 68506
University of Louisville
Louisville, Kentucky, 40202
Weill Cornell MC, NY
New York, New York, 10021
Mount Sinai Health System
New York, New York, 10029
Northwell Health, NY
New York, New York, 10075
Stony Brook University Hospital and Cancer Center
New York, New York, 11794-8191
AdventHealth Orlando
Orlando, Florida, 328803
AdventHealth Tampa
Tampa, Florida, 33613
About this study
Purpose: To validate the safety and effectiveness of xBar monitoring tool for detection of post-operative anastomotic leaks in subjects undergoing rectal/sigmoid resections with anastomosis.
The clinical team is blinded to the leak detection of the xBar system.
Read the detailed description
Study design: Pivotal, Prospective, Blinded, multi-center study. Study Population: This study will enroll approximately 190 eligible subjects undergoing scheduled colorectal surgery with anastomosis, without concomitant diversion.
xBar is an investigational device intended for post-op monitoring of patients undergoing GI surgery. The device is comprised of a surgical drain with embedded electrodes, connected to a small electronic device that records and relays data from the electrodes. The collected data is processed for early detection of complications.
Study description: The study is intended to validate the performance of the xBar system's anastomotic leak detection monitoring tool following colorectal resection with drain placement. During the index surgery the xBar device will be placed according to institution standard procedures and data recording will commence for a period of at least 3 days. Safety and complication detection performance will be evaluated retrospectively by comparing the diagnosis on a subject level done by the clinical team, who is blinded to xBar results, and the system.
- Conditions
- Colorectal Surgery, Anastomotic Leak
- Being tested
- xBar system
- Medical subject headings
- Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
xBar systemDiagnostic test
xBar system is surgical drain with embedded sensors. Collected data will be evaluated for an ability to identify anastomotic leaks. The xBar system does not have therapeutic indication.
| Study group | Role | What they receive |
|---|---|---|
| Singel arm | Other | All patients will be treated with the investigational device. Receives: Diagnostic Test: xBar system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Incidence of Unanticipated Serious Adverse Events Related to the xBar System or xBar Procedure
Measured: through study completion, an average of 1 year
Safety - Severe leak rate - comparable to SOC.
Incidence of Severe Anastomotic Leak. Statistical evaluation of prevalence of anastomotic leaks in the study group compared to the prevalence present in the literature.
Measured: through study completion, an average of 1 year
Performance - xBar Technical Success Rate
xBar Technical Success Rate
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Sensitivity
Sensitivity of xBar for Detection of Severe Anastomotic Leak assuming is non-inferior compared to Standard of care at POD 3
Measured: From the xBar placement up to POD3
Specificity
Specificity of xBar for Detection of Severe Anastomotic Leak assuming is non -inferior to standard of care detection
Measured: from the xBar placement up to post operative day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start11 Mar 2023
- Primary completion29 Sep 2025
- Study completion29 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal SurgeryStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- All eligible subjects will be assigned with the investigational device.
- Masking
- None (open label)
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Exero Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06168669
- Sponsor's protocol ID
- CLP03
- Status last verified
- Sep 2026
- First submitted
- 4 Dec 2023
- Last updated
- 17 Sep 2026
- Results posted
- 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 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Effectiveness Prospective Blinded Clinical Study to Validate xBar System as Monitoring Tool for Anastomotic Leaks Detection
- ClinicalTrials.gov ID
- NCT06168669
- Acronym / sponsor ID
- CLP03
- Conditions
- Colorectal Surgery, Anastomotic Leak
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Exero Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Mar 2023 (actual)
- Primary completion
- 29 Sep 2025 (actual)
- Study completion
- 29 Sep 2025 (actual)
- First posted
- 13 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: To validate the safety and effectiveness of xBar monitoring tool for detection of post-operative anastomotic leaks in subjects undergoing rectal/sigmoid resections with anastomosis.
The clinical team is blinded to the leak detection of the xBar system.
Detailed description
Study design: Pivotal, Prospective, Blinded, multi-center study. Study Population: This study will enroll approximately 190 eligible subjects undergoing scheduled colorectal surgery with anastomosis, without concomitant diversion.
xBar is an investigational device intended for post-op monitoring of patients undergoing GI surgery. The device is comprised of a surgical drain with embedded electrodes, connected to a small electronic device that records and relays data from the electrodes. The collected data is processed for early detection of complications.
Study description: The study is intended to validate the performance of the xBar system's anastomotic leak detection monitoring tool following colorectal resection with drain placement. During the index surgery the xBar device will be placed according to institution standard procedures and data recording will commence for a period of at least 3 days. Safety and complication detection performance will be evaluated retrospectively by comparing the diagnosis on a subject level done by the clinical team, who is blinded to xBar results, and the system.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All eligible subjects will be assigned with the investigational device.
| Arm | Type | Receives |
|---|---|---|
| Singel arm | Other | Diagnostic Test: xBar systemAll patients will be treated with the investigational device. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 22 years
- Indication for sigmoid or rectal resection surgery.
- Usage of drain during the surgery (to be confirmed during the surgery)
- Willing and able to comply with the study follow up.
- Able and agree to provide an informed consent.
Key exclusion criteria (7 listed)
- Contraindication for surgery and/or general anesthesia.
- Pregnancy or lactation.
- Planned or unplanned fecal diversion during the surgery (to be confirmed during the surgery)
- Known electronic device implanted in the chest or the abdominal cavity (e.g., pacemaker, cardioverter/defibrillator).
- Major medical or psychiatric illness or condition, or other factors that may affect general health or ability to adhere to the follow-up schedule.
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 |
|---|---|---|
| xBar systemxBar system is surgical drain with embedded sensors. Collected data will be evaluated for an ability to identify anastomotic leaks. The xBar system does not have therapeutic indication. | Diagnostic test | Singel arm |
Primary outcome
Safety
Time frame: through study completion, an average of 1 year
Incidence of Unanticipated Serious Adverse Events Related to the xBar System or xBar Procedure
Safety - Severe leak rate - comparable to SOC.
Time frame: through study completion, an average of 1 year
Incidence of Severe Anastomotic Leak. Statistical evaluation of prevalence of anastomotic leaks in the study group compared to the prevalence present in the literature.
Performance - xBar Technical Success Rate
Time frame: through study completion, an average of 1 year
xBar Technical Success Rate
2 secondary outcomes
Sensitivity
Time frame: From the xBar placement up to POD3
Specificity
Time frame: from the xBar placement up to post operative day 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing xBar system in people with Colorectal Surgery and Anastomotic Leak, run by Exero Medical Ltd. at 13 sites in 2 countries.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety (time frame: through study completion, an average of 1 year). The study lists 3 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 17 Sep 2026.