NCT03385109

Brief Summary

An open label observational registry trial in which participating centers enroll subjects who had or will have a laparoscopically assisted surgery using the Senhance Surgical System.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
22mo left

Started Jul 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Jul 2017Mar 2028

Study Start

First participant enrolled

July 25, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 28, 2017

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

September 16, 2025

Status Verified

September 1, 2025

Enrollment Period

10.4 years

First QC Date

December 20, 2017

Last Update Submit

September 10, 2025

Conditions

Surgery

Keywords

RoboticLaparoscopic

Outcome Measures

Primary Outcomes (1)

  • Adverse Event

    Any untoward sign symptom or disease

    Surgery to 30 days post op

Study Arms (1)

Senhance Treated

All patients enrolled who go on to have a surgery in which the Senhance system is used

Device: Surgery

Interventions

SurgeryDEVICE

Patients are approached surgically with the Senhance Surgical System

Senhance Treated

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients at a participating center who have had or are scheduled to have surgery using the Senhance system

You may qualify if:

  • patients 18-80 years old
  • Signed the informed consent
  • life expectancy 12 months or more

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Marien-Krankenhaus

Siegen, 57072, Germany

RECRUITING

MeSH Terms

Interventions

Surgical Procedures, Operative

Central Study Contacts

Stephanie Smith, PhD

CONTACT

608-957-4850ssmith@asensus.com

Monica Marini

CONTACT

+39 342 6268232mmarini@asensus.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2017

First Posted

December 28, 2017

Study Start

July 25, 2017

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

March 1, 2028

Last Updated

September 16, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)