Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area

Part of paid clinical trials in Orlando, Florida.

Sponsor
Boston Scientific Corporation
Study ID
NCT07035431
Status
Recruiting
Apply to this trial

Conditions

  • Anastomotic Leaks
  • Hartmanns Stump Leakage

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Endo-SPONGE — DEVICE
    The intervention involves the placement of an Endo-SPONGE in the leakage cavity, and applying suction to facilitate drainage.

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
May 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
66 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Endoscopic Vacuum Therapy (EVT) Device

Primary Outcome Measure

Serious Adverse Events [ Time Frame: Day 0 Study Procedure to end of study; up to 6 months ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Orlando Regional Medical CenterOrlandoFlorida32806
Antonio Caycedo, MD
[email protected]
407-422-3790
Antonio Caycedo, MD (PRINCIPAL_INVESTIGATOR)
Cleveland Clinic FloridaWestonFlorida33331
Marylise Boutros, MD
[email protected]
954-659-5757
Marylise Boutros, MD (PRINCIPAL_INVESTIGATOR)
Mount SinaiNew YorkNew York10029
Patricia Sylla
[email protected]
212-241-3547
Patricia Sylla, MD (PRINCIPAL_INVESTIGATOR)
Cleveland Clinic FoundationClevelandOhio44195
Emre Gorgun, MD
[email protected]
216-444-1244
Emre Gorgun, MD (PRINCIPAL_INVESTIGATOR)
Penn State HealthHersheyPennsylvania17033
Eric Pauli, MD
[email protected]
717-531-7462
Eric Pauli, MD (PRINCIPAL_INVESTIGATOR)
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107
Jennifer Miller, MD
[email protected]
215-955-5869
Jennifer Miller, MD (PRINCIPAL_INVESTIGATOR)
University of Washington Medical CenterSeattleWashington98195
Adam Templeton, MD
[email protected]
206-598-4377
Adam Templeton, MD (PRINCIPAL_INVESTIGATOR)
Marshall University Medical CenterHuntingtonWest Virginia25701
Wesam Frandah, MD
[email protected]
304-691-1830
Wesam Frandah, MD (PRINCIPAL_INVESTIGATOR)

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Orlando Regional Medical Center· Orlando, FLCleveland Clinic Florida· Weston, FLMount Sinai· New York, NYCleveland Clinic Foundation· Cleveland, OHPenn State Health· Hershey, PAThomas Jefferson University Hospital· Philadelphia, PA

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