ColoSeal™ ICD System Anastomotic Protection Pivotal Study

Conditions

• Rectal Cancer Surgery

Eligibility Criteria

Sex

ALL

Age

22 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• ColoSeal ICD System — DEVICE
  Subjects will undergo placement of the ColoSeal ICD Device without diverting ostomy placement during the index procedure.
• Protective Diverting Ostomy — PROCEDURE
  Subjects will undergo protective diverting ostomy placement during the index procedure.

Study Details

The purpose of this clinical investigation is to evaluate the safety of the ColoSeal ICD System by evaluating its effectiveness in reducing the stoma creation rate and by comparing the rate of major complications to current standard of care for rectal cancer surgery with a diverting ostomy.

Key Dates

First listed

Feb 24, 2026

Start date

Jun 19, 2026

Status verified

Aug 2026

Primary completion

Dec 31, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

250 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Treatment
• Active Comparator: Control

Primary Outcome Measure

Primary Safety Endpoint [ Time Frame: 270 days ]

Central Contacts

• Matthew Hammond, BA, CCRP
  650-799-6298
  [email protected]

Locations (6)

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