Colorectal Cancer study: XBar™ System
Official title Anastomotic Safety and Surveillance Using Real-time Enhanced Sensing Using xBar
ClinicalTrials.gov ID: NCT07337590
What this study is testing
- What it's testing
- The study aims to find out whether using the xBar system during surgery changes recovery outcomes for patients.
- Who it's for
- People having surgery for colorectal cancer.
- What's involved
- Participants will have the xBar system used during their operation and will be followed up to monitor recovery.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join if
- treatment Cohort
- Adults (≥21 years) scheduled for elective low anterior resection (by any surgical technique), due to colorectal cancer
- Expected anastomosis within 10 cm from the anal verge
- Usage of drain during the surgery (to be confirmed during the surgery)
- Willing and able to comply with the study follow up and able and agree to provide informed consent. Historical Cohort
You likely can't join if
- treatment Cohort
- people with benign disease
- Contraindication for surgery and/or general anesthesia.
- Known pregnancy or lactation.
- people receiving prophylactic stoma formation during index surgery (to be confirmed intraoperatively)
- Known electronic devices implanted in the chest or the abdominal cavity (e.g., pacemaker, cardioverter/defibrillator).
See the full eligibility criteria
- treatment Cohort
- Adults (≥21 years) scheduled for elective low anterior resection (by any surgical technique), due to colorectal cancer
- Expected anastomosis within 10 cm from the anal verge
- Usage of drain during the surgery (to be confirmed during the surgery)
- Willing and able to comply with the study follow up and able and agree to provide informed consent. Historical Cohort
- Adults aged ≥21 years at the time of surgery.
- Underwent a low anterior resection (LAR) for malignant colorectal disease.
- Documented colorectal anastomosis located \<10cm from the anal verge, or documented tumor \<10cm from the anal verge.
- treatment Cohort
- people with benign disease
- Contraindication for surgery and/or general anesthesia.
- Known pregnancy or lactation.
- people receiving prophylactic stoma formation during index surgery (to be confirmed intraoperatively)
- Known electronic devices 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 treatment study during the xBar system usage. Historical Cohort 1\. LAR performed for benign or non-oncologic indications (e.g., diverticulitis, inflammatory bowel disease, non-malignant...
The study team makes the final eligibility decision.
Where it is enrolling
- Louisville, Kentucky, United States
- Baltimore, Maryland, United States
- Lincoln, Nebraska, United States
- New York, New York, United States
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Louisville, Kentucky, United States; Baltimore, Maryland, United States; Lincoln, Nebraska, United States; New York, New York, United States; Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.