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Anastomotic Safety and Surveillance Using Real-time Enhanced Sensing Using xBar

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
21 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how using the xBar system affects recovery after surgery for cancer in the colon or rectum. It includes adults age 21 or older having planned surgery to remove part of the rectum, and records from adults who had this surgery before.

Purpose: To evaluate the effect of xBar system utilization on clinical outcomes during recovery following colorectal surgery.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • New surgery group: Age 21 or older and scheduled for planned surgery to remove part of the rectum because of colon or rectal cancer.
  • New surgery group: The bowel is expected to be joined back together within 10 cm of the anus.
  • New surgery group: A drain must be used during surgery. This will be confirmed during surgery.
  • New surgery group: Able and willing to complete follow-up visits and give informed consent, meaning you understand and agree to join.
  • Past surgery group: Was age 21 or older when having surgery to remove part of the rectum for colon or rectal cancer.
  • Past surgery group: Records show the bowel join or tumor was less than 10 cm from the anus.
  • Past surgery group: Complete records are available from the hospital stay and 12 months of follow-up, or until surgery to close the stoma, whichever came first. A stoma is an opening in the belly for bowel waste.

Who can't join

  • Either group: Surgery is for a condition other than cancer.
  • New surgery group: Cannot safely have surgery or general anesthesia, which puts you to sleep for surgery.
  • New surgery group: Known to be pregnant or breastfeeding.
  • New surgery group: A stoma, an opening in the belly for bowel waste, is made as a safety measure during surgery.
  • New surgery group: Has an electronic device implanted in the chest or belly, such as a pacemaker or defibrillator.
  • New surgery group: Has a major physical or mental health condition, or another factor, that may affect overall health or the ability to attend follow-up visits.
  • New surgery group: Has a known allergy to silicone, rubber, or stainless steel used in the xBar system.
  • New surgery group: Is in another study testing a treatment or device while using xBar.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: Interventional Cohort 1. Adults (≥21 years) scheduled for elective low anterior resection (by any surgical technique), due to colorectal cancer 2. Expected anastomosis within 10 cm from the anal verge 3. Usage of drain during the surgery (to be confirmed during the surgery) 4. Willing and able to comply with the study follow up and able and agree to provide informed consent. Historical Cohort 1. Adults aged ≥21 years at the time of surgery. 2. Underwent a low anterior resection (LAR) for malignant colorectal disease. 3. Documented colorectal anastomosis located \<10cm from the anal verge, or documented tumor \<10cm from the anal verge. Complete documentation for the index hospitalization and for the required 12-month follow-up period, or up to stoma take down procedure whichever came first. Exclusion Criteria: Interventional Cohort 1. Subjects with benign disease 2. Contraindication for surgery and/or general anesthesia. 3. Known pregnancy or lactation. 4. Subjects receiving prophylactic stoma formation during index surgery (to be confirmed intraoperatively) 5. Known electronic devices implanted in the chest or the abdominal cavity (e.g., pacemaker, cardioverter/defibrillator). 6. Major medical or psychiatric illness or condition, or other factors that may affect general health or ability to adhere to the follow-up schedule. 7. Known allergic reactions to materials used in the components of the xBar system, i.e., silicone, rubber and stainless-steel. 8. Participation in another interventional 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 strictures, fistula).

Study sites (6)

KY

MD

NE

NY

PA