Burlington, MANCT07035431Now EnrollingIRB Ready

Anastomotic Leaks Clinical Trial in Burlington, MA

Access cutting-edge anastomotic leaks treatment through this clinical trial at a research site in Burlington. Study-provided care at no cost to qualified participants.

Sponsored by Boston Scientific Corporation

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Expert Care in Burlington

Access anastomotic leaks specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related anastomotic leaks treatment provided free

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Check if you qualify for this anastomotic leaks clinical trial in Burlington, MA

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Why Participate?

  • No-Cost Study Care

  • Local to Burlington

    Convenient for MA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Burlington site if eligible
  4. 4Begin participation

About This Anastomotic Leaks Study in Burlington

This study is intended to evaluate the safety and effectiveness of Sponge-based Endoscopic Vacuum Therapy (EVT) using Endo-SPONGE for the treatment of Anastomotic Leaks (AL) or Hartmann's stump leakages following colorectal surgery in a prospective multi-center study.

Sponsor: Boston Scientific Corporation

Who Can Participate

Inclusion Criteria

Confirmed grade B anastomotic leak as per the ISGRC (International Study Group of Rectal Cancer) grading system after colorectal surgery.
Subject is eligible for endoscopic intervention.
Subject has a transmural defect of at least 2 cm in diameter following colorectal surgery in the lower pelvic area.
Subject has an anastomotic or Hartmann's stump leak located within an extraperitoneal cavity.
Subject has pre-existing diverting ostomy or an ostomy created prior to the first Endo-SPONGE placement.
Subject understands the trial requirements and is willing and able to comply with the study procedures, all protocol-required follow up evaluations and provide written informed consent to participate in the study.
Investigator decision that EVT is the most suitable treatment of the available treatment options.

Exclusion Criteria

Subject is under 18 years of age.
Potentially vulnerable subject, including, but not limited to pregnant women.
Subject has undergone EVT or other similar interventions for the current colorectal indication.
Subject had colorectal surgery more than 60 days prior to the planned study procedure.
Subject has any necrotic tissue that would require endoscopic debridement prior to Endo-SPONGE placement.
Subject has known contraindication for EVT as per the IB.
Subject is currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Burlington?

Yes, this clinical trial (NCT07035431) has an active research site in Burlington, MA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Anastomotic Leaks Treatment Options in Burlington, MA

If you're searching for anastomotic leaks treatment options in Burlington, MA, this clinical trial (NCT07035431) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Burlington research site is actively enrolling participants for this clinical trial. You'll receive care from experienced anastomotic leaks specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all anastomotic leaks clinical trials near you to find additional studies recruiting in your area.

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