Post-Market Study of the Signia Circular Stapler With Tri-Staple Technology in Left-sided Colon, Sigmoid, and Rectal Resections

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Medtronic - MITG
Study ID
NCT07351071
Status
Recruiting
Apply to this trial

Conditions

  • Anastomotic Complication
  • Anastomotic Leak
  • Anastomotic Leaks
  • Colonic Diseases
  • Colorectal Anastomosis
  • Digestive System Diseases
  • Gastrointestinal Diseases
  • Intestinal Diseases
  • Left-sided Colon Resection
  • Postoperative Complications
  • Rectal Diseases

Eligibility Criteria

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

Interventions

  • Signia™ circular stapler with Tri-Staple™ Technology (Signia™ Circular Stapling system) — DEVICE
    Signia™ Circular Stapling system used for the creation of an anastomosis

Study Details

The purpose of this study is to evaluate the safety and performance of the Signia™ power handle, Signia™ circular adapter, and Signia™ Tri-Staple™ 2.0 circular reloads (hereafter referred to as Signia™ circular stapler) in patients undergoing left sided colon, sigmoid, or rectal resections in a post market setting.

Key Dates

Start date
Dec 30, 2025
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Feb 28, 2027

Study Design

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

Arms

  • Experimental: Left sided colon/colorectal procedure with creation of an anastomosis
    single arm study, no control arm

Primary Outcome Measure

Incidence of anastomotic leak [ Time Frame: within 30 days, +/- 14 days ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Yale UniversityNew HavenConnecticut06520-
The University of South FloridaTampaFlorida33620-
Massachusetts General HospitalBostonMassachusetts02114-
Duke UniversityDurhamNorth Carolina27705-
The Ohio State University Wexner Medical CenterColumbusOhio43210-
Lankenau Institute for Medical ResearchWynnewoodPennsylvania19096-
University of Texas Health Science Center at HoustonHoustonTexas77030-
SSM Health St. Mary's Hospital - MadisonMadisonWisconsin53715-

Find similar trials in New Haven, CT

By research site
Yale University· New Haven, CTThe University of South Florida· Tampa, FLMassachusetts General Hospital· Boston, MADuke University· Durham, NCThe Ohio State University Wexner Medical Center· Columbus, OHLankenau Institute for Medical Research· Wynnewood, PA

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