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NCT03144765 · ClinicalTrials.gov registry record · NA

Multicenter Phase II Study of Transanal TME (taTME)

A NA study of Surgery and Rectal Cancer, sponsored by Icahn School of Medicine at Mount Sinai.

Active
Registry status
NA
Development phase
100
Enrollment target
12
Study locations

NCT03144765: Active NA study of Surgery and Rectal Cancer, sponsored by Icahn School of Medicine at Mount Sinai.

NCT03144765 is a NA study of Surgery and Rectal Cancer that is active but no longer recruiting, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 100 participants, below the 52,851-participant average among 120 other Surgery trials with a reported enrollment target (100% lower). The trial reports 12 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03144765, a NA study of Surgery and Rectal Cancer, is active but no longer recruiting, sponsored by Icahn School of Medicine at Mount Sinai.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
100 participants
Enrollment target
12
Study locations

Study Summary

Radical rectal cancer resection, namely total mesorectal excision (TME), is the cornerstone of the treatment of resectable rectal cancer. In combination with chemotherapy and radiation treatment (CRT), complete TME with negative resection margins is associated with sustained local and systemic control even in locally advanced disease. Over the last 2 decades, laparoscopic and robotic techniques have been increasingly adopted due to reduced surgical trauma and faster patient recovery. Yet, both approaches are associated with equivalent postoperative morbidity and disturbances in sexual, urinary and defecatory function relative to open TME. Furthermore, laparoscopic and robotic TME remain associated with substantial conversion rates and variable rates of TME completeness as a result of the procedural difficulties reaching the low rectum from the abdominal approach. Transanal TME (taTME) with laparoscopic assistance was developed to facilitate completion of TME using a primary transanal endoscopic approach. Transanal TME uses a "bottom-up approach" to overcome the technical difficulties of low pelvic dissection using an abdominal approach. Published results from single-center taTME series and an international registry suggest the short-term procedural and oncologic safety of this approach in resectable rectal cancer. No multicenter phase II study has yet been conducted to validate the procedural safety, functional outcomes or long-term oncologic outcomes of this approach. Study Design: This is a 5-year phase II multicenter single-arm study to evaluate the safety and efficacy of low anterior resection (LAR) with taTME using laparoscopic or robotic assistance in 100 eligible subjects with resectable rectal cancer. Hypothesis: taTME is non-inferior to standard LAR with respect to the quality of the TME achieved.

Primary Outcome

Rate of complete and near-complete mesorectal excision achieved with taTME, based on standard pathologic assessment of TME specimens.

Conditions Studied

Surgery Rectal Cancer

Interventions

  • PROCEDURE Transanal Total Mesorectal Excision (taTME)

Study Locations (12)

California

  • Kaiser Permanente - Los Angeles
  • Cedars Sinai Medical Center - Los Angeles
  • UC Irvine Hospital - Orange

Florida

  • Florida Hospital - Orlando
  • Cleveland Clinic Florida - Weston

New York

  • Mount Sinai Beth Israel - New York
  • Icahn School of Medicine at Mount Sinai - New York

Massachusetts

  • University of Massachusetts - Worcester

Ohio

  • Cleveland Clinic - Cleveland

Oregon

  • Providence Portland Medical Center - Portland

Pennsylvania

  • Lankenau Institute - Wynnewood

Other

  • Toronto Western Hospital - Toronto

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2017-09-25
Est. Completion 2027-04
Phase NA
Icahn School of Medicine at Mount Sinai

708 total trials

What the registry record for NCT03144765 still lists

NCT03144765 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 52,851-participant average among 120 other Surgery trials with a reported enrollment target (100% lower).

The record links to 2 conditions, with Surgery appearing as the primary indexed condition, and to 1 intervention - of which Transanal Total Mesorectal Excision (taTME) is the first listed.

NCT03144765 lists 12 locations in 8 states (California, Florida, New York).

Frequently Asked Questions

What is clinical trial NCT03144765 about?

NCT03144765 is a clinical study titled "Multicenter Phase II Study of Transanal TME (taTME)". Radical rectal cancer resection, namely total mesorectal excision (TME), is the cornerstone of the treatment of resectable rectal cancer. In combination with chemotherapy and radiation treatment (CRT), complete TME with negative resection margins is associated with sustained local and systemic contr...

What is the current status of trial NCT03144765?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2017-09-25. Estimated completion is 2027-04.

What conditions does trial NCT03144765 study?

This clinical trial studies the following conditions: Surgery, Rectal Cancer.

What interventions are being tested in trial NCT03144765?

The interventions under investigation include: Transanal Total Mesorectal Excision (taTME) (PROCEDURE).

Who is sponsoring clinical trial NCT03144765?

This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03144765 being conducted?

This trial has 12 study locations across California, Florida, Massachusetts, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03144765's enrollment target sits among peer trials

100 57th of 120 higher than 60 of 120 other Surgery trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Surgery trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT03144765, the US trial registry maintained by the National Library of Medicine. NCT03144765 (mid enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.