Mechanical Resistance Curves of the NTLC75 Linear Stapler During Barcelona Ileotransverse Anastomosis (NTLC75-ITA)

September 15, 2026 updated by: Ognjen Barčot, MD, PhD, University Hospital of Split

Relative Mechanical Resistance Curves of the NTLC75 Linear Stapler During Barcelona Ileotransverse Anastomosis After Right Colectomy: A Prospective Observational Pilot Study

This prospective single-center pilot cohort will include 40 consecutive adults undergoing elective right colectomy with a Barcelona ileotransverse anastomosis using an NTLC75/SR75 linear stapler. A sensor mounted externally on the stapler handle will record relative mechanical signals during two calibration closures without firing and two standard stapler activations. The main objectives are to obtain at least 35 technically valid final cross-stapling recordings and to estimate the association between the normalized final maximum signal and C-reactive protein on postoperative day 3. Clinical treatment is unchanged and follow-up continues through postoperative day 90.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Two close-only calibration measurements will be recorded once on double-walled small bowel and colon located on the resection-specimen side, outside the tumor and resection margins, with the anvil toward the mesentery, without firing or consuming additional reloads. The first standard activation forms the ileotransverse anastomotic channel without cross-stapling, with the anvil in the colon and reload jaw in the small bowel. The final closure is oriented with the device tip toward the small bowel so that knife travel proceeds from colon to small bowel and crosses two existing staple lines. The surgeon measures flattened tissue lengths and both cross-stapling distances with a sterile ruler to the nearest whole millimeter. Raw signals are preserved; forward and return branches are resampled to 200 normalized-time points. The signal is not calibrated as absolute force, is not shown to the surgeon and does not influence care. Other curve features and clinical outcomes are exploratory.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Croatia
      • Split, Croatia, 21000
        • University Hospital of Split, Department of Surgery
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults scheduled for elective right colectomy for operable right-sided colon cancer with planned primary Barcelona ileotransverse anastomosis using NTLC75/SR75.

Description

Inclusion Criteria:

  • Age 18 years or older
  • Elective right colectomy for histologically confirmed or clinically or radiologically suspected operable right-sided colon cancer
  • Planned primary Barcelona ileotransverse anastomosis using NTLC75/SR75
  • Capacity to understand the study and provide written informed consent

Exclusion Criteria:

  • Emergency surgery
  • No planned or performed primary anastomosis
  • Another anastomotic technique or stapler model
  • Withdrawal or inability to consent
  • Intraoperative change of plan preventing the planned measurement procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Elective Right Colectomy Cohort

Adults undergoing elective right colectomy with a Barcelona ileotransverse anastomosis using NTLC75/SR75 as standard clinical care. Relative mechanical signals are recorded passively during two close-only calibration closures without firing and two standard stapler activations.
Other: Passive External NTLC75 Handle-Signal Recording

An external DF9-40 sensor mounted on the NTLC75 handle passively records relative mechanical signals. One close-only calibration recording is obtained on double-walled small bowel and one on double-walled colon on the resection-specimen side, outside the tumor and resection margins, with the anvil toward the mesentery, without firing. Signals are also recorded during standard ITA channel formation (anvil in colon; reload jaw in small bowel; no cross-stapling) and final closure (tip toward small bowel; knife travel from colon to small bowel across two existing staple lines). The signal is not shown to the surgeon and does not affect clinical care.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Participants With a Technically Valid Final Cross-Stapling Signal Record
Time Frame: Intraoperative, during the final cross-stapling activation

Number and percentage of all 40 enrolled participants with a complete and technically valid final cross-stapling signal record. A valid record includes a complete forward branch, an identifiable reference return branch, no peak-obscuring saturation, no loss of sensor contact, and successful application of the locked signal-processing algorithm. Missing or invalid records remain in the denominator. Prespecified feasibility target: at least 35 of 40 participants.
Intraoperative, during the final cross-stapling activation
C-Reactive Protein Concentration on Postoperative Day 3 in Relation to the Normalized Final Maximum Signal
Time Frame: Postoperative day 3

Routine-care serum C-reactive protein in mg/L, analyzed continuously in association with the normalized maximum amplitude of the final cross-stapling forward branch using a scatterplot, Pearson or Spearman correlation, and simple linear regression.
Postoperative day 3

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
CloseMax During Small-Bowel Close-Only Calibration
Time Frame: Intraoperative, during the small-bowel close-only calibration

Maximum baseline-corrected relative signal amplitude during complete stapler closure on the double-walled small bowel located on the resection-specimen side, without firing. Reported in relative signal units.
Intraoperative, during the small-bowel close-only calibration
Maximum Signal Amplitude During ITA and Final Cross-Stapling Activations
Time Frame: Intraoperative, during the ileotransverse anastomotic-channel and final cross-stapling activations

Maximum baseline-corrected amplitude of each forward and return signal branch, calculated separately for the ileotransverse anastomotic-channel and final cross-stapling activations. Reported in relative signal units.
Intraoperative, during the ileotransverse anastomotic-channel and final cross-stapling activations
Inter-Rater Agreement for Manual Curve Classification
Time Frame: Through study completion and before database lock, an anticipated 16 months

Two independent raters blinded to C-reactive protein values and clinical outcomes classify technical validity, curve morphology, sticking, and irregularity for the ileotransverse anastomotic-channel and final cross-stapling recordings. Agreement between the two initial categorical ratings is quantified using Cohen's kappa before consensus resolution.
Through study completion and before database lock, an anticipated 16 months
C-Reactive Protein Concentration
Time Frame: Postoperative days 1 and 3

Routine-care serum C-reactive protein concentration recorded separately on postoperative days 1 and 3 and reported in mg/L. The prespecified association between postoperative-day-3 CRP and the normalized final cross-stapling maximum remains the second primary outcome.
Postoperative days 1 and 3
Highest Clavien-Dindo Complication Grade
Time Frame: From the index operation through postoperative day 90

Highest Clavien-Dindo grade assigned to any postoperative complication experienced by each participant through postoperative day 90. Participants without a complication are recorded as having no Clavien-Dindo complication.
From the index operation through postoperative day 90
Participants With Anastomosis-Related Events
Time Frame: From the index operation through postoperative day 90

Number and percentage of participants with anastomotic leak, anastomotic bleeding, perianastomotic collection or abscess, anastomosis-related radiologic or endoscopic intervention, reoperation, or surgical revision. Each event type is reported separately.
From the index operation through postoperative day 90
Length of Postoperative Hospital Stay
Time Frame: From the index operation to discharge from the index hospitalization, assessed through postoperative day 90

Number of calendar days from the index operation to discharge from the index hospitalization.
From the index operation to discharge from the index hospitalization, assessed through postoperative day 90
CloseMax During Colon Close-Only Calibration
Time Frame: Intraoperative, during the colon close-only calibration

Maximum baseline-corrected relative signal amplitude during complete stapler closure on the double-walled colon located on the resection-specimen side, without firing. Reported in relative signal units.
Intraoperative, during the colon close-only calibration
CloseMax During Ileotransverse Anastomotic Channel Formation
Time Frame: Intraoperative, during the stapler activation forming the ileotransverse anastomotic channel

Maximum baseline-corrected relative signal amplitude during the closing phase preceding the standard stapler activation used to form the ileotransverse anastomotic channel without cross-stapling. Reported in relative signal units.
Intraoperative, during the stapler activation forming the ileotransverse anastomotic channel
CloseMax During Final Cross-Stapling
Time Frame: Intraoperative, during the final cross-stapling activation

Maximum baseline-corrected relative signal amplitude during the closing phase preceding the final cross-stapling activation. Reported in relative signal units.
Intraoperative, during the final cross-stapling activation
Normalized Time to Maximum Signal Amplitude
Time Frame: Intraoperative, during the ileotransverse anastomotic-channel and final cross-stapling activations

Position of the maximum baseline-corrected amplitude within each signal branch, expressed as a percentage of that branch's total duration from 0% to 100%. Calculated separately for the forward and return branches of both activations.
Intraoperative, during the ileotransverse anastomotic-channel and final cross-stapling activations
Signal-Branch Duration During ITA and Final Cross-Stapling Activations
Time Frame: Intraoperative, during the ileotransverse anastomotic-channel and final cross-stapling activations

Actual elapsed duration of each forward and return signal branch, calculated separately for the ileotransverse anastomotic-channel and final cross-stapling activations. Reported in seconds from the preserved raw timestamps.
Intraoperative, during the ileotransverse anastomotic-channel and final cross-stapling activations
Signal Peak Count During ITA and Final Cross-Stapling Activations
Time Frame: Intraoperative, during the ileotransverse anastomotic-channel and final cross-stapling activations

Number of signal peaks identified by the locked signal-processing algorithm in each 200-point normalized-time branch. Calculated separately for the forward and return branches of both activations.
Intraoperative, during the ileotransverse anastomotic-channel and final cross-stapling activations
Maximum Signal Slope During ITA and Final Cross-Stapling Activations
Time Frame: Intraoperative, during the ileotransverse anastomotic-channel and final cross-stapling activations

Maximum positive slope of each 200-point normalized-time signal branch, calculated using the locked signal-processing algorithm. Reported in relative signal units per normalized-time point and calculated separately for both activations.
Intraoperative, during the ileotransverse anastomotic-channel and final cross-stapling activations
Area Under the Signal Curve During ITA and Final Cross-Stapling Activations
Time Frame: Intraoperative, during the ileotransverse anastomotic-channel and final cross-stapling activations

Area under each baseline-corrected 200-point normalized-time signal branch, calculated separately for the forward and return branches of both activations. Reported in relative signal units multiplied by normalized time.
Intraoperative, during the ileotransverse anastomotic-channel and final cross-stapling activations
Signal Amplitude Variability During ITA and Final Cross-Stapling Activations
Time Frame: Intraoperative, during the ileotransverse anastomotic-channel and final cross-stapling activations

Standard deviation of the baseline-corrected amplitudes across each 200-point normalized-time signal branch. Calculated separately for the forward and return branches of both activations and reported in relative signal units.
Intraoperative, during the ileotransverse anastomotic-channel and final cross-stapling activations
Leukocyte Count
Time Frame: Postoperative days 1 and 3

Routine-care peripheral blood leukocyte count recorded separately on postoperative days 1 and 3 and reported as ×10^9/L.
Postoperative days 1 and 3
Neutrophil Count
Time Frame: Postoperative days 1 and 3

Routine-care peripheral blood absolute neutrophil count recorded separately on postoperative days 1 and 3 and reported as ×10^9/L.
Postoperative days 1 and 3
Lymphocyte Count
Time Frame: Postoperative days 1 and 3

Routine-care peripheral blood absolute lymphocyte count recorded separately on postoperative days 1 and 3 and reported as ×10^9/L.
Postoperative days 1 and 3
Neutrophil-to-Lymphocyte Ratio
Time Frame: Postoperative days 1 and 3

Neutrophil-to-lymphocyte ratio calculated from the absolute neutrophil and lymphocyte counts obtained on the same postoperative day. Recorded separately on postoperative days 1 and 3 and reported as a unitless ratio.
Postoperative days 1 and 3
Serum Albumin Concentration
Time Frame: Postoperative days 1 and 3

Routine-care serum albumin concentration recorded separately on postoperative days 1 and 3 and reported in g/L.
Postoperative days 1 and 3
Serum Creatinine Concentration
Time Frame: Postoperative days 1 and 3

Routine-care serum creatinine concentration recorded separately on postoperative days 1 and 3 and reported in µmol/L.
Postoperative days 1 and 3
Estimated Glomerular Filtration Rate
Time Frame: Postoperative days 1 and 3

Laboratory-reported estimated glomerular filtration rate recorded separately on postoperative days 1 and 3 and reported in mL/min/1.73 m².
Postoperative days 1 and 3
Participants With a Major Postoperative Complication
Time Frame: From the index operation through postoperative day 90

Number and percentage of participants experiencing at least one major postoperative complication, defined as Clavien-Dindo grade III, IV, or V.
From the index operation through postoperative day 90
Comprehensive Complication Index Score
Time Frame: From the index operation through postoperative day 90

Comprehensive Complication Index score calculated from all postoperative complications experienced by each participant through postoperative day 90. Reported on the standard continuous scale from 0, indicating no complication, to 100, indicating death.
From the index operation through postoperative day 90
Participants With All-Cause Readmission Within 30 Days
Time Frame: From discharge after the index hospitalization through postoperative day 30

Number and percentage of participants with at least one unplanned all-cause hospital readmission by postoperative day 30.
From discharge after the index hospitalization through postoperative day 30
Participants Undergoing Reoperation Within 30 Days
Time Frame: From the index operation through postoperative day 30

Number and percentage of participants undergoing at least one unplanned surgical reoperation for any cause by postoperative day 30.
From the index operation through postoperative day 30
All-Cause Mortality Within 30 Days
Time Frame: From the index operation through postoperative day 30

Number and percentage of participants who die from any cause by postoperative day 30.
From the index operation through postoperative day 30
All-Cause Mortality Within 90 Days
Time Frame: From the index operation through postoperative day 90

Number and percentage of participants who die from any cause by postoperative day 90.
From the index operation through postoperative day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital of Split

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 3, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 29, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 8, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NTLC75-PILOT-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Patient-level data will not be made public because the small single-center surgical cohort carries a material re-identification risk.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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